Phase 3 Stomach Cancer Trial, Recruiting NCT06532006 Sponsor: Shanghai Henlius Biotech Condition: Stomach Cancer
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Phase 3 Stomach Cancer Trial, Recruiting

NCT06532006
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:

  • Adults aged 18 or older at the time of signing the consent form
  • People with a confirmed diagnosis (through tissue or cell testing) of HER2-positive stomach or gastroesophageal junction cancer that has not been treated before, and that has either spread to nearby areas and cannot be surgically removed, or has spread to other parts of the body
  • People whose cancer can be measured on scans, assessed according to standard guidelines — the measurable areas must not be limited to bone spread only
  • People whose cancer tests HER2-positive, confirmed by a central laboratory using specific tissue staining and/or genetic testing methods (IHC 3+, or IHC 2+ with ISH+ or FISH+)
  • People with a general health performance score of 0 or 1 on the ECOG scale (meaning fully active or able to carry out light activity) within 7 days before being assigned to a treatment group
  • People with an expected survival of at least 6 months
  • People whose organ function (such as liver, kidneys, and blood counts) meets adequate levels as defined by the trial

Who may not be able to join:

  • People who have had another cancer in the 2 years before joining the trial
  • People whose stomach or gastroesophageal junction cancer got worse within 6 months of finishing earlier chemotherapy or radiotherapy given before or after surgery
  • People who have previously received any treatment that specifically targets HER2
  • People who have active bleeding in the stomach or digestive tract
  • People who have cancer that has spread to the brain or central nervous system
  • People whose heart pumping function (left ventricular ejection fraction) is below 55%
  • People with a known history of severe allergic reactions to any monoclonal antibody or to any component of the study treatment

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: +86 18810366427

Australian sites

St. Vincent Hospital Melbourne, Fitzroy, Melbourne
Peninsula Health-Frankston hospital, Frankston, Melbourne
University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic, Sunshine Coast, Queensland
GenesisCare Research, Campbelltown, Sydney
Central Coast Local Health District (Gosford and Wyong Hospital), Gosford, Sydney
Macquarie University, North Ryde, Sydney
Concord Repatriation General Hospital, Concord,

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
Shanghai Henlius Biotech
Registry
ClinicalTrials.gov
Start date
22 November 2024
Est. completion
1 June 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇱 Chile 🇨🇳 China 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇯🇵 Japan 🇵🇪 Peru 🇵🇱 Poland 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇺🇸 United States

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

Primary endpoints

Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee); Overall Survival (OS)

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