Referential content
Financial statements
From our Treasurer,
Grant Mundell
Over the 2025 calendar year, our organisation has maintained a sound financial position, with performance in line with Board expectations. Total income remained strong at $15,869,898 supported by valued corporate partnerships, generous philanthropic support, and continued grant funding, enabling ongoing investment in our collaborative research.
Expenditure was carefully managed in line with strategic priorities, with the majority of funds directed toward advancing our research portfolio and delivering key scientific and educational activities. The organisation closed the year with a deficit of $389,250, and reserves remain within the Board’s target range, providing a solid foundation for future initiatives.
As part of our new organisational strategy for 2025-2030, a key focus is on building the capacity of our organisation and strengthening revenue diversification to support long-term sustainability. This is important to the ongoing development of independent, patient focused research to improve outcomes for all those affected by GI cancers.
On behalf of the Board, I thank our members, partners, sponsors, and donors for their ongoing support, which is critical to enabling our purpose and impact.
2025 Year at a glance
January
- The MASTERPLAN pancreatic cancer study closed to recruitment on 6 January. A total of 75 patients were enrolled to the study.
- We welcomed Gemma Collett to the Research Team as the Translational Research Coordinator.
- We farewelled Professor Cheri Ostroff who stepped down from our Community Advisory Panel. It was with great sadness that Cheri passed away only a few weeks later.
- We farewelled Nisha Berthon-Jones, Head of Research Operations, after nearly 7 years of service.
- Results from the ASCEND, INTEGRATE/INTEGRATE IIa and SPAR trials, were presented as posters at ASCO Gastrointestinal Cancers Symposium in San Francisco, USA.
- Pan tumour study ICEMELT and rectal cancer study RENO closed for recruitment, with 231 and 124 patients enrolled respectively.
- Jennie Vu, our Events Coordinator, welcomed a beautiful baby boy.
February
- John Paduano held his annual Golf Day on 28 February, raising $9,800 in honour of his son Alex who passed away from bowel cancer in 2018.
- The MONARCC clinical trial findings were published in the Clinical Colorectal Cancer Journal.
- The IMPERIAL anal cancer trial opened to recruitment with a target of 28 patients.
- Patient recruitment target of 56 (102%) was reached for our ACME ABC biliary tract cancer clinical trial.
March
- The STOPNET clinical trial was presented as a poster at the 2025 European Neuroendocrine Tumour Society Conference (#ENETS2025) in Krakow, Poland.
- Clinical Development Lead, Louise Christophersen, presented at the Australian Clinical Trials Alliance/Australian Teletrial Program summit on our experience relating to teletrials.
- The ALT-GIST clinical trial findings were published in the British Journal of Cancer.
- Community Advisory Panel (CAP) member Brooklynn Dowling hosted a fundraising event at the ADF School of Health in Albury, raising $1,732 for oesophageal cancer trials.
- We proudly launched Seedpod of Yarns, a new library of video resources created by Madison Shakespeare, Gadigal Traditional Owner and former CAP member.
April
- The Kangaroo Island Gutsy Challenge, led by Associate Professor Amitesh Roy, along with 10 other trek participants, raised over $54,000.
May
- After more than 6 years of service, we farewelled Liz Thorp from our Board of Directors.
- The TOPGEAR clinical trial findings were presented at the European Society for Radiotherapy and Oncology (ESTRO) Congress in Vienna, Austria, and at the International Gastric Cancer Congress (IGCC) in Amsterdam, Netherlands, by Study Chair Professor Trevor Leong.
- We held our eighth Idea Generation Workshop, this time focused on Early-Phase Study Designs.
- Alexia Trikilis joined the team in the newly-created role of Operations Manager.
- The colorectal cancer trial, Neo-POLEM, opened for recruitment with a target of 44 patients across Australia and the UK.
- We farewelled John Paduano who stepped down from our CAP.
June
- Our clinical trials STOPNET, DYNAMIC-III, NEO-IMPACT and endorsed study CHALLENGE featured at the world-leading cancer research meeting, American Society of Clinical Oncology (ASCO) in Chicago, USA.
- In collaboration with Omico, Pancare Foundation and Pankind, we held an informative webinar for medical professionals on 'Latest developments on the role of molecular tumour testing in pancreatic cancer'.
- Community fundraiser Jenny Horn, along with her team at Harcourts Yeppoon raised over $7,000 at their golf event, held in memory of Jenny's husband, Rusty Horn.
July
- Preliminary Cohort B data from the ASCEND pancreatic cancer clinical trial was presented at the European Society for Medical Oncology (ESMO) GI Congress in Barcelona, Spain by Study Chair Associate Professor Andrew Dean.
- The community-funded MR STAR abdominal cancer trial opened to recruitment.
- The OXTOX colorectal cancer trial successfully completed recruitment, enrolling 100 patients. OXTOX was funded by our generous GI cancer community.
August
- Lis Boyce from Piper Alderman and Team Pierre Fabre Australia ran Sydney's City2Surf and raised a combined total of $4,000.
- The gastro-oesophageal cancer trial, INTEGRATE IIa, was presented as a poster at the International Society of Clinical Biostatistics (ISCB) Conference.
- The iLSTA pancreatic cancer trial successfully completed recruitment, enrolling 30 patients.
- The 2025 Preceptorship in Colorectal Cancer brought together 29 early-career members and 11 expert members across medical oncology, surgery, radiation oncology and radiology.
- After an extensive consultation and development process beginning in March, we launched our 2025–2030 organisational strategy.
- The Research Executive Committee (REC) was established to provide a central, strategic role in our research development process. The REC was formed by merging the Research Operations and Scientific Advisory Committees.
September
- The TOPGEAR clinical trial findings were presented at the American Society of Radiation Oncology (ASTRO) Congress in San Francisco, USA by Study Chair Professor Trevor Leong.
- Our DOCTOR TR oesophageal cancer clinical trial was presented as a poster at International Society for Diseases of the Esophagus (ISDE) Congress in Brisbane, Australia.
- The OMEGCA gastro-oesophageal cancer trial was awarded an oral presentation at the AANZGOSA Annual Scientific Meeting.
- Sandra Bahamad was appointed as our Head of Research.
- We welcomed Dr Atefeh Khakpoor, who is covering for Dr Sarah Hayes as our Translational Research and Grants Lead while Sarah is on parental leave.
- The Blue Mountains Gutsy Challenge, led by Sarah Sutherland, raised $47,000.
October
- The DYNAMIC-III and INTEGRATE IIb clinical trial findings were presented at the European Society For Medical Oncology (ESMO) Congress in Berlin, Germany by Professor Jeanne Tie and Professor David Golstein respectively.
- Our clinical trials ASCEND, ASCOLT TR, Neo-POLEM and TOPGEAR were presented as posters at the European Society For Medical Oncology (ESMO) Congress in Berlin, Germany.
- The Lachlan Kean Foundation hosted their annual gala dinner which was attended by GI Cancer Trials staff and volunteers.
- We were delighted to welcome four new CAP members: Gemma Farquhar, Katrina Kendall, Melissa Bodenham and Nicole Kroesche.
- We welcomed Jamila Birkan to the team in the newly created role, Clinical Trial Project Coordinator.
- Dr Sarah Hayes, our Translational Research and Grants Lead, welcomed a gorgeous little girl.
November
- Our 27th Annual Scientific Meeting was held in Tarntanya / Adelaide, themed ‘Transforming Trials through Collaboration’.
- We announced our new name, GI Cancer Trials, to members.
- The PemOla pancreatic cancer trial opened to recruitment.
- ASM Abstracts were published in Wiley Guide (published by Asia-Pacific Journal of Clinical Oncology).
- We welcomed Daniel Pittorino to our Board of Directors.
- Jason Long and Gordon Porter completed the 5-day Massive Murray Paddle kayak challenge, raising over $11,300 to support the BIL-PPP trial.
- Kms for Kaz running team raised close to $5,000 in their Fernleigh 15 Newcastle run to support stomach cancer research.
- Riversdale Golf Club’s Women’s Charity Committee held their annual golf event, raising $12,000 to support pancreatic cancer research.
- Results from the TOPGEAR trial helped change international best practice guidelines published by the American Society for Radiation Oncology (ASTRO).
December
- The Mike Leeke Foundation raised an incredible $9,000 at their annual Mike Leeke Classic golf day.
- The RESOLUTE colorectal cancer clinical trial closed for recruitment.
- The RoLaCaRT-1 clinical trial findings were published in Surgical Endoscopy.
- An important milestone was reached, enrolling the 10,000th trial participant since our establishment in 1991.
- We were delighted to welcome Nick Verry to our CAP.
Grants
Infrastructure grants
Cancer Australia provides funding through the Support for Cancer Clinical Trials Program with the primary aim to support GI Cancer Trials to develop industry-independent cancer clinical trials.
Cancer Australia funding is for three years, from 1 July 2024 to 30 June 2027. The grant provides GI Cancer Trials with up to $1,585,145 in infrastructure funding over the grant period.
Research grants
Funds provided by Cancer Australia, Cancer Council, the National Health and Medical Research Council (NHMRC) and the Medical Research Future Fund (MRFF) in support of trial coordination may be managed through third-party Administering Institutions (AI) including the University of Sydney NHMRC Clinical Trials Centre and the Walter and Eliza Hall Institute (WEHI), in addition to GI Cancer Trials. Funds managed by third parties are transferred to GI Cancer Trials to support site payments and insurance costs relating to these studies and are reflected as such in these financial accounts.
Grants supporting trials conducted during the 2025 financial year are outlined below. GI Cancer Trials grant income and expenditure during the 2025 year for these trials are included in the 2025 Income Statement.
GI Cancer Trials may also contribute additional operational funding to support these studies beyond grant income. This support is funded through community donations, trial-specific fundraising appeals, or discretionary reserves.
BIL-PPP
Open-label, single-arm, signal-seeking phase II study of the combination of durvalumab and olaparib in advanced cholangiocarcinoma after initial chemotherapy and durvalumab.
Funding AI: GI Cancer Trials (formerly Australasian Gastro-Intestinal Trials Group)
- Tour de Cure Senior Research Grant: $200,000 (2024)
DYNAMIC-RECTAL
This initial study has been designed to determine whether a ctDNA-based approach to adjuvant therapy will lead to substantially less patients receiving adjuvant therapy.
Funding AI: Walter and Eliza Hall Institute
- NHMRC Project Grant: $1,316,682 (2017)
MASTERPLAN
This study aims to determine if adding stereotactic body radiotherapy (SBRT) to modern chemotherapy (mFOLFIRINOX or gemcitabine/nab-paclitaxel) for patients with high-risk or unresectable (also called locally advanced) pancreatic cancer improves cancer control rates in and around the pancreas.
Funding AI: University of Sydney NHMRC Clinical Trials Centre
- Medical Research Future Fund: $1,512,808 (2018)
NABNEC
A Randomised Phase II Study of NAB-Paclitaxel in Combination with Carboplatin as First Line Treatment of Gastrointestinal Neuroendocrine Carcinomas.
Funding AI: University of Sydney NHMRC Clinical Trials Centre
- NHMRC Project Grant: $360,750 (2016)
PemOla
A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with mismatch repair deficiency or tumour mutation burden ≥ 4 mutations/Mb.
Funding AI: GI Cancer Trials (formerly Australasian Gastro-Intestinal Trials Group)
- PanKind Research Grant: $297,548 (2024)
- Tour de Cure Matching Grant: $50,000 (2024)
- Epworth Medical Foundation Research Grant: $30,550 (2024)
RESOLUTE
Randomised Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer.
Funding AI: Walter and Eliza Hall Institute
- Cancer Council Victoria Grant: $299,548 (2021)
SPAR
Simvastatin with chemotherapy and radiation in preoperative treatment for rectal cancer: a randomized, placebo-controlled phase 2 trial.
Funding AI: University of Sydney NHMRC Clinical Trials Centre
- Cancer Society of New Zealand Grant: $149,290 NZD (2015)
- Cancer Council NSW Grant: $449,448 AUD (2016)
- Cancer Australia Grant: $148,857 AUD (2017)
SSGXXII
Three or five years of adjuvant imatinib for the treatment of patients with operable GIST with a high risk of relapse: A randomized phase III study.
Funding AI: University of Sydney NHMRC Clinical Trials Centre
- Medical Research Future Fund: $1,036,125 (2021)
STOPNET
Comparison of patient outcomes with or without continuation of somatostatin injections after the commencement of Peptide Receptor Radionuclide Therapy (PRRT).
Funding AI: GI Cancer Trials (formerly Australasian Gastro-Intestinal Trials Group)
- Tour de Cure Grant 2022: $50,000 (2023)
- Medical Research Future Fund Clinical Trial Activity Grant 2023: $1,285,405 (2024)
TOPGEAR NHMRC
A randomised phase II/III trial of pre-operative chemoradiotherapy versus pre-operative chemotherapy for resectable gastric cancer.
Funding AI: University of Sydney NHMRC Clinical Trials Centre
- NHMRC Grant: $756,136 (2013)
- NHMRC Grant: $621,644 (2021)
Publications and presentations
Publications
ALT-GIST
Desmond Yip, John Raymond Zalcberg, Jean-Yves Blay, Mikael Eriksson, David Espinoza, Timothy Jay Price, Sandrine Marreaud, Antoine Italiano, Neeltje Steeghs, Kjetil Boye, Craig Underhill, Val Gebski, John Simes, Hans Gelderblom, Heikki Joensuu. Imatinib alternating with regorafenib compared to imatinib alone for the first-line treatment of advanced gastrointestinal stromal tumor: The AGITG ALT-GIST Intergroup randomized phase II trial. Br J Cancer. 2025 Mar 25. doi: 10.1038/s41416-025-02983-w.PMID: 40133509.
ASCOLT
John Chia, Eva Segelov, Yan Hong Deng, Gwo Fuang Ho, Wang Wei, Shuting Han, A. Shama, KeFeng Ding, Gong Cheng, Mark Jeffreys, Chee Kian Tham, Joong Bae Ahn, Louise Nott, Robert Zielinski, Tsui-Yi Chao, Tom van Hagen, Po-Li Wei, Fiona Day, Shaesta Mehta, Thomas Yau, Jie-Wen Peng, Theresa Hayes, Yong Li, Mihir Gandhi, Estelle M.J. Foo, Nabilah Rahman, Peter Rothwell, Raghib Ali, John Simes, Han Chong Toh.Aspirin after completion of Standard Adjuvant Therapy for Colorectal Cancer (ASCOLT) – An International Phase 3 Randomised Placebo-controlled Trial. Lancet Gastroenterol Hepatol. 2025 Jan 14:S2468-1253(24)00387-X. doi: 10.1016/S2468-1253(24)00387-X. Epub ahead of print. PMID: 39824200.
DYNAMIC III
Jeanne Tie; Yuxuan Wang; Jonathan Loree; Joshua D. Cohen; Rachel Wong; Timothy Price; Niall Tebbutt; Val Gebski; David Espinoza; Matthew Burge; Sam Harris; James Lynam; Belinda Lee; Margaret Lee; Daniel Breadner; Marlyse Debrincat; Siavash Foroughi; Lorraine Chantrill; Stephenie Lim; Sharleen Gill; Chris O’Callaghan; Janine Ptak; Natalie Silliman; Lisa Dobbyn; Maria Popoli; Chetan Bettegowda; Nicholas Papadopoulos; Kenneth W. Kinzler; Bert Vogelstein; Peter Gibbs, for the DYNAMIC-III Study Group (Intergroup Study of the Australasian Gastro-Intestinal Trials Group and Canadian Cancer Trials Group). Circulating Tumor DNA-Guided Adjuvant Therapy in locally advanced colon cancer: the randomized phase 2/3DYNAMIC -III trial.https://doi.org/10.1038/s41591-025-04030-w Published 20Oct 2025
INTEGRATE and INTEGRATE Iia
Yu Yang Soon; Katrin Sjoquist; Ian C. Marschner; I. Manjula Schou; Nick Pavlakis; David Goldstein; Kohei Shitara; Martin R. Stockler; John Simes; Andrew J. Martin. INTEGRATE pooled phase II/III results are robust to post-progression switching and winner’s curse. JNCI Cancer Spectrum, pkaf053, https://doi.org/10.1093/jncics/pkaf053 Published: 02 June 2025
INTEGRATE and INTEGRATE Iia
Sayeda Kamrun Naher, David Espinoza, Peter Grimison, Kohei Shitara, Nick Pavlakis, David Goldstein, Martin Stockler, Rebecca Mercieca-Bebber, Katrin Marie Sjoquist. Development and Validation of a Prognostic Model incorporating patient reported outcomes for Advanced Gastric and Oesophageal Carcinoma (AGOC) Using Individual Patient Data from Two AGITG Clinical Trials. Gastric Cancer. https://doi.org/10.1007/s10120-025-01654-2, published 16 September 2025.
MONARCC
Matthew E. Burge, David Espinoza, Katrin Marie Sjoquist, Derrick HW Sui, Rebecca Mercieca-Bebber, Lorraine A. Chantrill, Christos Stelios Karapetis, Christopher B. Steer, Sonia Yip, Jeff Cuff, Stephanie Winata, Jeanne Tie, Darshit Arunbhai Thaker, Ratnesh Srivastav, Ehtesham Abdi, Andrew Strickland, Eva Segelov, Alessandra Francesconi, Timothy Price, Rahul Ladwa, Warren Joubert, Niall C. Tebbutt. AGITG MONARCC: A randomized phase 2 study of panitumumab monotherapy and panitumumab plus 5-Fluorouracil as first-line therapy for RAS and BRAF wild type metastatic colorectal cancer. A study by the Australasian Gastro-Intestinal Trials Group (AGITG). Clin Colorectal Cancer. Epub Dec 2024, 2025 Jun;24(2):120-128. doi: 10.1016/j.clcc.2024.11.003.
OMEGCA
David S. Liu, Zexi Allan,Jeanne Tie, Katheryn Hall, Margaret M. Lee, Darren J. Wong, Stephen Q. Wong, Niall C. Tebbutt, David I. Watson, Markus Trochsler, Krinal Mori, Nicole Winter, Sarah Martin, Geraldine Ooi, Yahya Al-Habbal, Ronald Ma, Bert Vogelstein, Nicholas J. Clemons. Multi-omics evaluation of peritoneal fluid in gastroesophageal cancer (OMEGCA): protocol for a prospective multicentre cohort study to detect occult peritoneal metastases in patients undergoing curative-intent treatment. PLOS ONE 20(4): e0318615. https://doi.org/10.1371/journal.pone.0318615
ROLACART
Stevenson ARL, Khan JS, Wilson K, O'Connell RL, Pillinger S, Lynch C, Francis NK, Curtis NJ, Miskovic D, Clouston AD, Miller GC, Chow CFK, Warrier S, Heriot AG, Tonkin D, Bell S, Muhlmann MD, Austin KKS, Gillespie CJ, Larson DW, Temple L, Pigazzi A, Mercieca-Bebber R, Simes J. RoLaCaRT-1: pilot randomised phase II study of robotic vs laparoscopic hemicolectomy for right colon cancer. Surg Endosc. 2025 Dec 10. doi: 10.1007/s00464-025-12400-1. Epub ahead of print. PMID: 41372621.
Presentations
ACME ABC
Owen McKay, Joanne Lundy, Sally Bell, Phil Ha, Dean Seah, Hugh Gao, Brendan J. Jenkins, Chamkaushalya Bulathsinghalage, Michael Swan, Simon Hew, Pranav Dorwal, Sean Grimmond, Andrew Perry, Trevor Wilson, Andrew H. Strickland, Nam Nguyen, Daniel Croagh. The Australian Comprehensive Molecular Evaluation of Advanced Biliary Cancer Trial (AGITG ACME ABC). Biennial Congress of the European-African Hepato-Pancreato-Biliary Association (June 2025) - oral presentation
ASCEND
Andrew Dean, Marion Harris, Katrin Marie Sjoquist, Val Gebski, Christos Stelios Karapetis, Chris Lomma, Matthew E. Burge, Christopher B Steer, Niall Tebbutt, Belinda Lee, Christopher GCA Jackson, Fiona Day, Shamsudheen Padinharakam, James Murray, Kristen K Buck, Jan Mumford, Derrick HW Siu, Joanna Lee, Yan Ru Gao, Timothy Price. AGITG ASCEND: Randomised, Double-Blind Phase II Trial of Certepetide (CERT) or Placebo (PLA) Added to Gemcitabine (Gem) and Nab-Paclitaxel (Nab) in Patients with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC): Updated Results Including Planned Pooled Placebo Analysis. ESMO (October 2025) - poster presentation.
ASCEND
Andrew Peter Dean, Marion Harris, Katrin Sjoquist, Val Gebski, Christos Stelios Karapetis, Chris Lomma, Matthew E. Burge, Christopher B. Steer, Niall C. Tebbutt, Belinda Lee, Christopher G. C. A. Jackson, Fiona Day, Shamsudheen Padinharakam, James Murray, Sonia Yip, Jan Mumford, Derrick HW Siu, Joanna Lee, Yan Ru Gao, Timothy Jay Price. AGITG ASCEND study: Randomised, double-blind phase II study of certepetide (CERT) or placebo (PLA) added to gemcitabine plus nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma—Cohort B progression free survival (PFS) results. ESMO GI (July 2025) - oral presentation.
ASCEND
Andrew Dean, Katrin Sjoquist, Val Gebski, Christos Karapetis, Chris Lomma, Matthew Burge, Christopher Steer, Niall Tebbutt, Belinda Lee, Christopher Jackson, Fiona Day, Shamsudheen Padinharakam, James Murray, Sonia Yip, Jan Mumford, Derrick Siu, Joanna Lee, Yan Ru Gao, Marion Harris*, Timothy Price (study co-chair)*. AGITG ASCEND: Randomised, double-blind phase II study of LSTA/ placebo added to gemcitabine and nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma: initial results. ASCO GI (January 2025) - poster presentation
ASCOLT TR
John Simes, Shan Li, Isabel Li, Daphne Day, Dmitri Mouradov, Sonia Yip, Val Gebski, GM Jeffery, R Zelinski, L Nott, GF Ho, T Chao, Siti Nabilah, E Foo, JWK Chia, HC Toh, Oliver Sieber, Eva Segelov. Adjuvant aspirin for colorectal cancers (CRC) in patients with PIK3CA-mutated and COX-2 overexpressed tumours: the ASCOLT Translational (TR) study. ESMO (October 2025) - poster presentation.
DOCTOR TR
Clemence J. Belle, Sandra Brosda, Vanessa F. Bonazzi, Yung-Ching Kao, Ian Brown, Lauren G. Aoude, Mitchell S. Stark, Kalpana Patel, AGITG DOCTOR Investigators, Victoria Atkinson, Andrew P. Barbour. Spatial transcriptomics profiling of the tumour microenvironment of oesophageal adenocarcinoma. ISDE Congress (September 2025) - Poster of Distinction.
DYNAMIC-III
Jeanne Tie, Yuxuan Wang, Jonathan Loree, Joshua D Cohen, David Espinosa, Rachel Wong, Tim Price, Niall Tebbutt, Chris O’Callaghan, Chetan Bettegowda, Nickolas Papadopoulos, Kenneth Kinzler, Bert Vogelstein and Peter Gibbs. ctDNA-Guided Adjuvant Chemotherapy De-Escalation in Stage III Colon Cancer: Primary Analysis of the ctDNA-Negative Cohort from the Randomized AGITG DYNAMIC-III Trial (Intergroup Study of AGITG and CCTG). ESMO (LBA) - oral presentation.
DYNAMIC-III
Jeanne Tie, Yuxuan Wang, Jonathan Loree, Joshua D Cohen, David Espinosa, Rachel Wong, Tim Price, Niall Tebbutt, Margaret Lee, Matthew Burge, Sam Harris, Belinda Lee, James Lynam, Chris O’Callaghan, Daniel Breadner, Chetan Bettegowda, Nickolas Papadopoulos, Kenneth Kinzler, Bert Vogelstein, Peter Gibbs. ctDNA-Guided Adjuvant Chemotherapy Escalation in Stage III Colon Cancer: Primary Analysis of the ctDNA-Positive Cohort from the Randomized AGITG DYNAMIC-III Trial (Intergroup Study of AGITG and CCTG). ASCO (May/June 2025) - oral presentation.
INTEGRATE and INTEGRATE IIa
Yu Yang Soon; Katrin Sjoquist; Ian C. Marschner; I. Manjula Schou; Nick Pavlakis; David Goldstein; Kohei Shitara; Martin R. Stockler; John Simes; Andrew J. Martin. Methodological considerations of planning a phase 3 trial based on a phase 2 trial: lessons from the AGITG INTEGRATE trials. ACTA 2025 Oral presentation, Nov 2025
INTEGRATE and INTEGRATE IIa
Sayeda Kamrun Naher, David Espinoza, Peter Grimison, Kohei Shitara, Nick Pavlakis, David Goldstein, Martin Stockler, Rebecca Mercieca-Bebber, Katrin Marie Sjoquist. Development and Validation of a Prognostic Model for Advanced Gastric and Oesophageal Carcinoma (AGOC) Using Individual Patient Data from Two Clinical Trials. ASCO GI (January 2025) - poster presentation
INTEGRATE IIa
Ding Ma, Patrick Maher, Andrew Martin. A Semiparametric Joint Model to Account for Longitudinal Response and Non-Proportional Hazards. ISCB-Switzerland ASBCB 2025 (September 2025) - poster presentation.
INTEGRATE IIB
D. Goldstein, K. Sjoquist, D. Espinosa, S.Y. Rha, T. Goetze, N. Tebbutt, H. Hara, K.-W. Lee, M.H. Ryu, E. Goekkurt, P. Thuss-Patience, G.M. Haag, S. Lorenzen, J. Simes, C. Karapetis, T. Price, D. Siu, M. Moehler, K. Shitara, N. Pavlakis. Regorafenib plus nivolumab vs investigator’s choice of chemotherapy in previously treated gastric or gastroesophageal junction (GEJ) adenocarcinoma: Primary analysis of the randomized phase 3 AGITG INTEGRATE IIb study. ESMO (LBA) - oral presentation.
NABNEC
Grace Kong, Narjess Ayati, Chris Brown, Derrick Siu, John Mak, Lorraine Chantrill, Mustafa Khasraw, John Simes, Michael Christie, Chris Karapetis, David Chan, Michael S. Hofman. The role of [18F]FDG (FDG) PET/CT as a prognostic biomarker for patients with Grade 3 neuroendocrine neoplasms (NEN) – the AGITG NABNEC trial. ANZSNM (May 2025) - oral presentation.
NABNEC
Grace Kong, Narjess Ayati, Chris Brown, Derrick Siu, John Mak, Lorraine Chantrill, Mustafa Khasraw, John Simes, Michael Christie, Chris Karapetis, Michael S. Hofman, David Chan. [18F]FDG (FDG) PET/CT metrics as prognostic biomarkers in the AGITG NABNEC trial. eNETS (March 2025)- poster presentation
NEO-IMPACT
L Chantrill, J Samra, N Tebbutt, M Nikfarjam, D Reid, M Jaber, J Tie, S Mendis, W Hong, T Cavicchiolo, J Cuff, S Hayes, L Christopherson, M Roesner, S Maloney. NEO-adjuvant chemo-immunotherapy in pancreatic cancer: results of the AGITG NEO-IMPACT pilot trial. ASCO (May/June 2025) -poster presentation.
NEO-POLEM
T Dhillon, G Griffiths, S Crabb, S Ewings, K-A Longman, T Price, T Krishnan, S Bahamad, J Mak, S Hayes, J Kuszewski, D Hathorn. Neo-POLEM: A phase II trial of neoadjuvant PD-1 vaccine PD1-Vaxx in operable MSI high colorectal cancer. ESMO (October 2025) - poster presentation.
OMEGCA
Zexi Allan, Yuxuan Wang, Jeanne Tie, Niall Tebbutt, Nicholas Clemons, Nickolas Papadopoulos, Kenneth Kinzler, Bert Vogelstein, David S. Liu on behalf of the OMEGCA study group. Multi-Omics Evaluation of Peritoneal Fluid in Gastroesophageal Cancer: results from interim analysis. ISDE Conference (Sept 2025) - oral presentation.
OMEGCA
Zexi Allan,Hillary S. Sloane, Kneshay Harper, Sasha Witts, Brodie Bilston, Maree Pechlivanis, Hannah Quinn, Daniel L. Edelstein, Niall Tebbutt, Nicholas Clemons, David S. Liu, on behalf of the OMEGCA study group. Post-surgery circulating tumour DNA as a biomarker for predicting disease recurrence in gastro-oesophageal cancer patients undergoing curative-intent treatment. AANZGOSA ASM (Sept 2025) - oral presentation.
OMEGCA
Brodie Bilston, Zexi Allan, Sasha Witts, David Liu, Nicholas Clemons. Optimisation of Cell Free Tumour DNA Extraction From Peritoneal Lavage Fluid For Biomarker Analysis. Lorne Cancer (February 2025) - poster presentation
SPAR
Michael B Jameson, Kirsten Gormly, David Espinoza, Michael Arendse, Derrick HW Siu, AiIsa Langford, Mark Jeffery, Christos Stelios Karapetis, Swetha Sridharan, Matthew E Burge, Anne O’Donnell, Andrew Oar, Angela Mweempwa, James Armstrong, Timothy Jay Price, Samuel Y Ngan, Frank Frizelle, Andrew Stevenson, Katrin Marie Sjoquist, Stephen P Ackland. AGITG SPAR: A Randomized Placebo-Controlled Phase II trial of Simvastatin in addition to Neoadjuvant Chemotherapy and Radiation for Rectal Cancer. Waikato Clinical Campus Biannual Research Seminar (March 2025) - oral presentation.
SPAR
Michael B. Jameson, Kirsten Gormly, David Espinoza, Michael Arendse, Derrick HW Siu, Ailsa Langford, Mark Jeffery, Christos Stelios Karapetis, Swetha Sridharan, Matthew E. Burge, Anne O'Donnell, Andrew Oar, Angela Mweempwa, James Armstrong, Timothy Jay Price, Samuel Y Ngan, Frank Frizelle, Andrew Stevenson, Katrin Marie Sjoquist, Stephen P. Ackland. AGITG SPAR: A randomized placebo-controlled phase II trial of simvastatin in addition to neoadjuvant chemotherapy and radiation for rectal cancer. ASCO GI (January 2025) - poster presentation
STOPNET
M. Burge, D. Wyld, D. Pattison, S. Bahamad, S.A. Hayes, J. Kuszewski , L. Chantrill, T.J. Price, H. Wong, D. Chan, P. Grover, M. Michael, D. Siu, C. Bishop, D. Barker, R. Goodwin, C. O’Callaghan, J. Loree, W.J. Mak. AGITG STOPNET – A randomized study of cessation of somatostatin analogues after peptide receptor radionuclide therapy in Mid, Hind-Gut, and Pancreatic Neuroendocrine Tumours. ASCO (May/June 2025) -poster presentation.
STOPNET
Burge MA, Wyld DA, Pattison DA, Loree JB, Goodwin RC, Chantrill LD, Karapetis CE, Barker DF, Bahamad SG, Hayes SA, Kuszewski JG, Mak W J. Australasian Gastro-Intestinal Trials Group (AGITG) STOPNET: A randomized study of cessation of somatostatin analogues after peptide receptor radionuclide therapy (PRRT) in Mid, Hind-Gut, and Pancreatic Neuroendocrine tumours. eNETS (March 2025)- poster presentation
TOPGEAR
Phillip Chlap, Mark Lee, Trevor Leong, Matthew Field, Jason Dowling, Hang Min, Julie Chu, Jennifer Tan, Phillip Tran, Tomas Kron, Annette Haworth, Laurence Court, Martin Ebert, Shalini Vinod, Lois Holloway. Automated Clinical Target Volume Contour Quality Assurance for the TOPGEAR Trial. American Society for Radiation Oncology (ASTRO) (Oct 2025) - oral presentation.
TOPGEAR
Julia Lai-Kwon, Michael Jefford, Rachel L O’Connell, Jolie Ringash, John Simes, B. Mark Smithers, Michael Michael, Karin Haustermans, Rebecca KS Wong, Trevor Leong. Quality of life in people with stomach/gastroesophageal junction (GOJ) cancers in TOPGEAR. ESMO (October 2025) - poster presentation.
TOPGEAR
Leong T. TOPGEAR – a randomized phase 3 trial of perioperative chemotherapy with or without preoperative chemoradiotherapy for resectable gastric cancer. ESTRO 2025 Congress (European Society for Radiotherapy and Oncology) (May 2025) - oral presentation
TOPGEAR
Leong T. TOPGEAR – a randomized phase 3 trial of perioperative chemotherapy with or without preoperative chemoradiotherapy for resectable gastric cancer. 16th International Gastric Cancer Congress (IGCC)(May 2025) - oral presentation
TOPGEAR
Leong T. TOPGEAR - A randomized phase III trial of perioperative chemotherapy with or without preoperative chemoradiotherapy for resectable gastric cancer: Final results from an intergroup trial of AGITG, TROG, EORTC and CCTG. West Lake Gastric Cancer Congress (April 2025) - oral presentation
TOPGEAR
Leong T. Perioperative management of oesophago-gastric cancer. UK and Ireland Oesophagogastric Cancer Group (UKIOG) Annual Meeting (March 2025) - oral presentation.
TOPGEAR
Leong T. A randomized phase III trial of perioperative chemotherapy (periop CT) with or without preoperative chemoradiotherapy (preop CRT) for resectable gastric cancer (AGITG TOPGEAR): Final results from an intergroup trial of AGITG, TROG, EORTC and CCTG. Trans-Tasman Radiation Oncology Group (TROG) 37th Annual Scientific Meeting, (March 2025) - oral presentation
