New drug combo shows promise in shrinking aggressive stomach tumors before surgery
NCT ID NCT07273981
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called zanidatamab, given with chemotherapy before surgery, for people with a specific type of stomach or gastroesophageal junction cancer that has high levels of HER2 protein. The goal is to see if this combination can shrink tumors more effectively than standard treatment. About 30 adults with stage II or III cancer will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent. 2. Histologically/radiologically confirmed Stage II/III (cT1-2N+M0 or cT3-4aNanyM0) Siewert II/III GEJ/gastric adenocarcinoma. 3. HER2-high (IHC 3+/2+FISH+); HER2 2+ requires FISH (no time restriction). 4. Age 18-75, any gender. 5. ECOG 0-1, surgically eligible. 6. Adequate organ function for abdominal surgery. 7. Life expectancy ≥3 months. Exclusion Criteria: Exclusion Criteria 1. Unresectable/metastatic (Stage IV) disease. 2. Prior systemic GC therapy. 3. Other malignancies within 5 years (except those with \>90% 5-year survival). 4. Cardiopulmonary dysfunction. 5. Major surgery within 4 weeks pre-study. 6. Severe infection within 4 weeks. 7. Prior chemo/targeted therapy. 8. Hypersensitivity to study drugs/excipients/mAbs. 9. Factors impairing oral intake (e.g., ≥Grade 2 dysphagia/chronic diarrhea). 10. Uncontrolled comorbidities affecting compliance/outcomes. 11. Pregnancy/lactation/planned pregnancy. 12. Immunosuppression (\>10mg/day prednisone equivalent within 2 weeks). 13. Active HBV (DNA ≥1×10³ copies/mL or ≥200IU/mL), HCV+, or HIV+. 14. Other antitumor trials within 28 days. 15. Other high-risk conditions (e.g., psychiatric disorders) per investigator. 16. Refusal to sign consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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