Phase 2 Oesophageal Cancer Trial, Recruiting NCT06290505 Sponsor: Australasian Gastro-Intestinal Trials Group Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT06290505
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a male or female aged 18 or older
  • You have been diagnosed with a specific type of cancer (adenocarcinoma or squamous cell carcinoma) of the esophagus (food pipe) or the area where the esophagus meets the stomach, confirmed by a biopsy
  • Your cancer has either spread to a limited number of places in the body (1–5 spots outside the main treatment area, seen on a special scan), or it is locally advanced and cannot be treated with surgery or high-dose radiation therapy
  • You have difficulty swallowing that is causing symptoms
  • You are reasonably active and able to care for yourself, at least some of the time (confirm with trial site)
  • Your doctor estimates you are likely to live for more than 12 weeks
  • You weigh more than 30 kilograms (about 66 pounds)
  • Your blood cell counts are at acceptable levels (checked through a blood test; blood transfusions to reach these levels are allowed)
  • Your liver is working well enough, based on blood test results
  • Your kidneys are working well enough, based on blood test results
  • A sample of your tumour tissue (from a previous biopsy or surgery) is available for testing
  • You are willing and able to follow all the requirements of the study
  • You have read and signed a consent form agreeing to take part

Who may not be able to join:

  • Your cancer has spread widely or is threatening an organ in a way that your doctor feels needs stronger chemotherapy right away
  • Your cancer tests positive for a specific protein called HER2 and the disease has spread to other parts of the body
  • You have already received systemic (whole-body) treatment such as chemotherapy for this cancer
  • You have previously had radiotherapy to your chest area (though prior radiation to bone pain spots is allowed)
  • You currently have a stent (a small tube) placed in your esophagus
  • You have a known abnormal opening between your esophagus and your airway (tracheo-esophageal fistula)
  • The cancer has spread to your brain or the lining around your brain
  • You have had a major operation within the last 28 days before starting the study
  • You have been diagnosed with another cancer in the past 3 years, with some exceptions such as certain treated skin cancers (confirm with trial site)
  • You have previously been treated with certain types of immunotherapy drugs that target immune checkpoint pathways (confirm with trial site)
  • You have moderate or severe nerve damage causing numbness or tingling (confirm with trial site)
  • You have a known allergy to any of the study drugs, or you have an active autoimmune disease (a condition where your immune system attacks your own body), such as inflammatory bowel disease, lupus, or rheumatoid arthritis — though some milder conditions like vitiligo, well-controlled thyroid problems, type 1 diabetes, or coeliac disease managed by diet may still be acceptable (confirm with trial site)
  • You are currently taking steroid tablets at a moderate-to-high dose or other medicines that suppress your immune system (some forms of steroids such as inhalers or creams may still be acceptable — confirm with trial site)
  • You have a current hepatitis B infection (those with a past resolved infection may still be eligible — confirm with trial site)
  • You have an active hepatitis C infection
  • You have HIV or active tuberculosis (TB)
  • You have received a transplanted organ (such as a kidney, liver, heart, or lung) or a bone marrow transplant from a donor
  • You have received a live vaccine within the last 30 days before joining the study
  • You have used alternative or traditional medicines within the last 14 days before joining the study
  • You have another serious uncontrolled illness, such as an active infection, uncontrolled heart or lung problems, or a mental health condition that would make it difficult to safely take part
  • You are pregnant, breastfeeding, or not using reliable contraception — specific contraception requirements apply for both women and men during and after the study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Fiona Day, Dr, Calvary Mater Newcastle

Phone: 02 7208 2714

Australian sites

Canberra Hospital, Garran, Australian Capital Territory
5124 5288
Border Medical Oncology, Albury, New South Wales
Calvary Mater Newcastle, Newcastle, New South Wales
Royal Brisbane and Women's Hospital, Herston, Queensland
Flinders Medical Centre, Bedford Park, South Australia
St Vincent's Hospital, Fitzroy, Victoria
Peter MacCallum Cancer Centre, Melbourne, Victoria
Sir Charles Gairdner Hospital, Nedlands, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Australasian Gastro-Intestinal Trials Group
Registry
ClinicalTrials.gov
Start date
8 December 2021
Est. completion
31 July 2027

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT scan and clinical review.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov