Our research
We pursue meaningful and targeted research, working to put our strategy into practice.
How we conduct research
Our research focuses on improving outcomes for people with GI cancer. We’re continuing to implement our five-year research strategy, developed in 2022, to grow our portfolio of trials, build on local and international collaborations, and focus on quality assurance and quality improvements. 18 studies were open to patient recruitment in 2024.
Our research strategy
In 2024, we worked on strengthening the reach, relevance and impact of our research through six strategic activities:
- Proactively focussing on equity, diversity and inclusion to enhance equitable cancer care.
- Broadening and diversifying the membership and committee representation.
- Expanding access to and involvement in our research across Australia and Aotearoa New Zealand.
- Fostering an innovative culture that encourages use of new trial designs and technology.
- Actively involving and supporting early and mid-career researchers in the planning, design, development and conduct of our research.
- Driving collaboration and partnership opportunities with funders, patient support groups, and pharmaceutical companies to access investigational product and devices.
We see potential for more growth and collaboration in the research areas of prevention/screening, diagnosis and survivorship.
From our Scientific Advisory Committee Chair,
Professor Chris Karapetis
2024 was a significant year for AGITG research. It was fantastic to see the first trial coordinated by the AGITG Clinical Research Centre, STOPNET, open in September. The Centre is a new business model for AGITG, and provides high quality, efficient and timely trial coordination services. We look forward to the opening of Neo-POLEM and PemOla in 2025, both coordinated by the AGITG Clinical Research Centre.
This year we expanded our capabilities in the AGITG Research Team. We welcomed Research Fellow Dr John Mak, Quality Assurance Specialist Amy Bruce, Clinical Development Coordinator Bridget Rooney, Clinical Operations Lead Miriam Roesner and Clinical Project Coordinator Ingrid Laycock.
The growth of the team enables our focus to remain on ensuring our compliance as Sponsor, with a particular focus on quality assurance and quality improvements. We ran the second round of the ICH Guidelines for Good Clinical Practice training for our research leaders and AGITG employees. Several of our committees’ Terms of Reference were thoroughly refreshed to be more descriptive and representative of the respective committee’s function. These activities promote a culture of excellence, ensuring that quality remains central to everything we do.
Our committees were as active as ever in 2024. We welcomed new members to the International Development Committee, which plays an increasingly important role in fostering connections with key opinion leaders and trials groups from around the world. These collaborations help expand AGITG’s footprint and bring new research to Australia and Aotearoa New Zealand.
We continue to provide many pathways for members to develop new ideas with the Group. Nine new concepts were brought through the Working Parties and two concepts were prioritised by the SAC in 2024. The New Concepts Symposium proved a highlight of the Annual Scientific Meeting and the seventh AGITG Idea Generation Workshop was held in May to develop new ideas for anal cancer research.
We celebrated several trial milestones in 2024, with recruitment targets achieved for the NEO-IMPACT pancreatic cancer trial and INTEGRATE IIb gastroesophageal trial. Three new trials opened to patients with colorectal cancer, cholangiocarcinoma and neuroendocrine tumours: BIOMARCER-2, BIL-PPP and STOPNET.
Our research gained significant recognition in 2024. The AGITG TOPGEAR gastroesophageal cancer clinical trial findings were published in the New England Journal of Medicine and was simultaneously presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain by Study Chair Professor Trevor Leong.
The INTEGRATE IIa study was published in the Journal of Clinical Oncology, FORECAST-1 was published in Cell Reports Medicine, and a translational substudy of our oesophageal cancer trial DOCTOR was published in Genome Medicine. Several of our trials also featured at the annual ASCO and ASCO GI meetings including DYNAMIC-Pancreas, MONARCC, NEO-CREATE, DYNAMIC-Rectal and NABNEC.
We ended the year on a positive note with grant success. Thank you to Tour de Cure for awarding a $100,000 grant to the REGATTA colorectal cancer trial and a $200,000 grant to the cholangiocarcinoma trial, BIL-PPP.
I would like to thank the entire membership for your engagement with AGITG this year. I look forward to continuing my work with the Scientific Advisory Committee in 2025 to develop clinical trials that offer people with GI cancer hope for a brighter future.
Scientific Advisory Committee Chair
Our research priorities
Our research priorities drive our decisions around our research focus and our methods. Based on these priorities, we can make pragmatic and considered decisions on current gaps in GI cancer research with what is feasible.
Cancer types of focus
HCC
(primary liver cancer
and liver SBRT)
Rectal cancer
Late-stage disease (especially colorectal cancer)
Global collaboration for cancers
Research types of interest
Pragmatic trial designs
Basket studies
Overarching considerations within research activity
“Outside of the box”
thinking
Patient reported outcomes
Partnerships & collaborations
Our research process
Our Research Development and Prioritisation Framework is a formal and collaborative process to streamline how we assess and prioritise research concepts. When a concept is reviewed, it is evaluated based on:
- scientific merit
- feasibility
- alignment with AGITG strategy
- likelihood of funding
- organisational risk, and
- financial risk.
When research is progressed through the Framework, it is refined at every stage. Study Chairs are given multidisciplinary and community feedback to integrate into their research proposal, adding value.
What we’re researching
What is a clinical trial?
Cancer clinical trials are carefully designed research studies that investigate new practice or treatment options. Trials may look at whether a new treatment is better than standard available treatments, or whether a specific intervention can manage cancer symptoms or treatment side effects. Trials can also look at the quality-of-life aspects of cancer treatment, addressing the effects that cancer and cancer treatment can have on the wellbeing of the patient, their families, and carers.
While clinical trials offer the opportunity to help researchers study better diagnostic or treatment options for people with cancer, they also offer people hope for a brighter future. Additionally, patients on clinical trials may be better informed about treatment options, be more closely monitored by health professionals, and have greater access to new treatments.
The AGITG has studies that we sponsor, and studies we endorse. Endorsed AGITG studies are pilot studies which are sponsored and conducted by other institutions. By endorsing these studies, we can give scientific input when they are in development and, once these studies are active, support awareness and recruitment through promotional activities. The data gathered through pilot studies can then be used to inform and lead n turn helps them develop data that we could use to support and lead AGITG-sponsored, large-scale studies in the future.
Sites are medical centres that offer the trial treatment as part of the study. Patients attend appointments at these sites for the trial treatment. Excitingly, some AGITG studies are now incorporating a teletrial component, which means that patients can have elements of their trial treatment closer to where they live.
Our research achievements
In 2024, our INTEGRATE IIb stomach and oesophageal cancer clinical trial completed recruitment of 462 patients. Reaching this milestone means that this clinical trial can benefit the maximum number of people possible and ensure the robustness of the study results.
The ACTICCA-1 clinical trial, which is assessing whether post-surgery chemotherapy can improve outcomes for biliary tract cancer patients, reached international recruitment of 789 patients with 66 sites globally.
The NEO-IMPACT clinical trial also achieved its patient enrolment target, enrolling 20 Australians with pancreatic cancer. In a significant milestone for all involved, NEO-IMPACT was the first AGITG trial to be fully-funded by community and philanthropy. The NEO-IMPACT translational research study on the microbiome was also funded by philanthropy.
These outcomes shape clinical practice, improve future patient care, and often inspire new trials or further research, advancing medical knowledge.
Thank you to all the generous patients and their families who participated in these studies, and to the sites and members involved for their commitment to the studies.
We opened three new trials for people with GI cancer in 2024:
- BIOMARCER-2 will explore whether patients with right-sided advanced colon cancer, who also have a certain biomarker, experience better outcomes when treated with anti-EGFR therapy. This study is based on the importance of personalising medicine – making treatment work for patients with as much effectiveness as possible, while minimising side effects. BIOMARCER-2 is funded from a GI Cancer Institute-funded Innovation Grant.
“Rather than using the side of the colon in which their cancer originated, we will measure markers we think will indicate which patient will respond. We will essentially be sparing patients who won’t benefit from certain drugs the toxicity of it and undergoing the process of using ineffective therapies,” says Dr Shehara Mendis, Study Chair of BIOMARCER-2.
- BIL-PPP, a world-first study, aims to evaluate the efficacy and tolerability of two drugs used together as ongoing treatment for patients with locally advanced or metastatic cholangiocarcinoma, after they have completed initial chemotherapy.
Initial funding came via a patient through the Wayne Elphinstone Research Fund with additional community funding from the GI Cancer Institute and a Tour De Cure grant.
- STOPNET is investigating whether monthly injections are still needed for patients with neuroendocrine tumours (NETs) after they've received radiation therapy. STOPNET is the first trial coordinated by the AGITG Clinical Research Centre and the first study to come under the Commonwealth Neuroendocrine Tumour research collaborative(CommNETs), which brings together NETs researchers from Australia, Aotearoa New Zealand and Canada. This trial is generously funded through AGITG philanthropy, a Tour De Cure grant and a Medical Research Future Fund (MRFF) Grant.
AGITG CEO Joanne Cory says: “Launching our own coordinating centre is a significant milestone for the AGITG, as we can now provide our members with exclusive access to quality central coordination services. Thank you to our Clinical Research Centre team for your incredible efforts in establishing the Centre.”
“It means the world to us that we have the support and trust of the GI cancer community. Thank you so much.”
Professor Lorraine Chantrill
Study Chair of NEO-IMPACT
We were thrilled to receive significant grant funding in 2024 for two new studies:
- The REGATTA colorectal cancer clinical trial was awarded a $100,000 Matching Research Grant for Tour de Cure Australia.
- The BIL-PPP cholangiocarcinoma clinical trial was awarded a $200,000 Grant from Tour de Cure Australia.
Studies open to patients in 2024
The following table lists all AGITG studies that eligible patients in 2024 could participate in.
Our Translational Research Program
The AGITG Translational Research (TR) Program aims to add value to important clinical trials in GI cancer by supporting the collection and use of biospecimens for future research.
Translational research is a feature of many of our trials – more than 90% of our ongoing trials involve the collection of patient samples for future GI cancer research.
Our TR Program assists us to develop translational research in GI cancers by providing access to these stored biological specimens acquired from AGITG trials. The Program is directed by the AGITG Translational Research Committee, comprised of experts whose specialties include biological research, medical oncology, surgery and pathology, and consumer representation.
We want to sincerely thank all the participants across our trials who have donated their precious samples to help us build our biobank. These samples, given freely and possessing such personal, spiritual and cultural importance, are the foundation of our future GI cancer research. We are very grateful and privileged to be the custodians of these invaluable samples, with our research only possible due to the generosity of those patients.
From our Translational Research Lead,
Dr Sarah Hayes
I am thrilled to report that our Translational Research (TR) program has gone from strength to strength during 2024. Our Program has been specifically designed to support the development of new TR that can be in-built into future trials to help secure the future of innovative research here at AGITG.
Since the TR Program was established, over 90% of ongoing and newly designed studies (directly funded or sponsored by AGITG) are collecting samples for future research use. Following completion of any predetermined TR substudies built into our trials, any remaining material is banked for use by external researchers through our Sample Access Program.
We are very fortunate, and incredibly grateful, that our TR Program is skilfully overseen by our TR Committee, whose members are experts in the fields of biological research, medical oncology, surgery and pathology.
In 2024, we had some exciting new TR concepts come through the Committee for review. One of these concepts, OPTIC, was the first concept to be endorsed through our new TR Endorsed Study model. This study was first presented to AGITG at our 2023 Late-Stage Colorectal Cancer Idea Generation Workshop and recently received a 2023 MRFF Genomics Health Futures Grant to fund this work. This vital research, led by TR Committee Chair Professor Vicki Whitehall, will use state of the art technologies to predict which therapy is most likely to benefit individual patients with bowel cancer, and develop new biomarkers and practices that can be implemented clinically to improve outcomes for these patients.
I am also delighted to report that our TR study, OMEGCA, funded under a 2023 AGITG Innovation Grant, has achieved 50% participant recruitment in less than seven months. This exciting research, led by Dr David Liu and Associate Professor Nick Clemons, seeks to develop and validate an accurate molecular test to detect microscopic spread of stomach cancer in the abdominal cavity.
Similarly, I am very pleased to report that prospective recruitment for the STING study has been completed. This study, led by Associate Professor Weng Ng, is undertaking research into whether levels of a protein called STING will be useful in determining which patients with stomach or oesophageal cancer should be receiving what type of treatment, such as chemotherapy or immunotherapy.
On behalf of the AGITG team, I want to sincerely thank our committed membership for their support and for collaborating with us on new and exciting research ideas. Most importantly, I want to express my deep gratitude to the study participants who have so generously donated their samples to further GI cancer research – without their gift, our work is simply not possible.
Translational Research Lead
What is translational research?
Translational research is often referred to as ‘bench to bedside’. It aims to take what is learned at the lab bench into results that can directly benefit patients. For example, tumour samples provided by patients during a clinical trial can be used by researchers to find biological characteristics of that tumour that are associated with good response to the drugs used in AGITG trials. If the response to the drug used in the trial is not as good as expected, they can also use these samples to try and find out why.
Our publications and presentations
In 2024, several of our trials were published in leading medical journals and presented at the world’s largest forums for clinical cancer research. The DYNAMIC-Pancreas, MONARCC and NEO-CREATE trials featured at the world-leading cancer research meeting by the American Society of Clinical Oncology (ASCO) in Chicago. Abstracts for the DYNAMIC-Rectal and NABNEC trials were presented at ASCO’s Gastrointestinal Cancers Symposium held in San Franscisco.
AGITG TOPGEAR clinical trial findings were published in the New England Journal of Medicine and presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain by Study Chair Professor Trevor Leong, drawing the attention of clinicians from all over the globe.
