Phase 3 Oesophageal Cancer Trial, Recruiting NCT07431281 Sponsor: AstraZeneca Condition: Oesophageal Cancer
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Phase 3 Oesophageal Cancer Trial, Recruiting

NCT07431281
Recruiting Phase 3 🇦🇺 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 must be able to give your signed agreement to take part in the study.
  • You must be at least 18 years old (or the legal age of consent in your country) when you sign the consent form.
  • You have been diagnosed with a type of cancer called adenocarcinoma affecting the stomach, the junction between the stomach and food pipe, or the lower part of the food pipe — and it has not been treated before, cannot be removed by surgery, has spread locally, or has spread to other parts of the body.
  • Your tumor has been tested and shows a protein called CLDN18.2 on its surface, confirmed by a central lab test.
  • Your tumor has been tested for a protein called PD-L1, and based on those results and your doctor's assessment, you will be placed into one of two groups (confirm with trial site for details on which group applies to you).
  • You are generally well enough to carry out light daily activities, with no significant decline in the two weeks before joining the study (confirm with trial site).
  • You are expected to live for at least 12 weeks.
  • You have at least one area of cancer that can be measured or tracked using standard imaging scans.
  • Your liver, kidneys, and bone marrow are functioning well enough as specified by the study (confirm with trial site for exact requirements).
  • You weigh at least 35 kg (about 77 lbs).
  • You meet the study's requirements around contraception during the trial (confirm with trial site for details).

Who may not be able to join:

  • Your cancer has tested positive for a protein called HER2.
  • You have significant or unstable bleeding in your stomach, or untreated stomach ulcers.
  • You have an active autoimmune or inflammatory condition that requires treatment with steroids or other immune-suppressing medicines, or your doctor feels participation would put you at undue risk.
  • You have a condition affecting your brain or central nervous system (confirm with trial site for specifics).
  • You have significant fluid build-up around your lungs or in your abdomen, especially if it needs to be drained or managed with a catheter.
  • You need to be fed through a drip (intravenously) because of a blockage in your stomach or digestive system.
  • You have noticeable nerve problems affecting sensation or movement in your hands or feet (confirm with trial site for exact grading).
  • You still have side effects from a previous cancer treatment (other than hair loss) that have not settled back to a mild level.
  • You have certain heart problems as outlined by the study (confirm with trial site for specifics).
  • You have uncontrolled diabetes or diabetes-related nerve damage within the last 3 months.
  • You have certain active or uncontrolled infections, including hepatitis A, B, or C, or HIV that is not well managed.
  • You have a known deficiency of an enzyme called DPD, either partial or total.

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 27 July 2026
Phase 3: approximately ~65% 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

Phone: 1-877-240-9479

Australian sites

Research Site, Darlinghurst,
Research Site, Garran,
Research Site, Heidelberg,
Research Site, Murdoch,
Research Site, Randwick,
Research Site, Westmead,

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 3
Sponsor
Registry
ClinicalTrials.gov
Start date
3 February 2026
Est. completion
16 August 2029

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Progression Free Survival (PFS) (Cohort 1 and Cohort 2); Overall Survival (OS) (Cohort 1)

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: 27 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