Targeted antibody combo aims to shrink HER2-Positive stomach cancers before surgery
NCT ID NCT07685704
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial investigates whether adding the targeted antibody zanidatamab to standard chemotherapy can shrink HER2-positive stomach or gastroesophageal junction cancers before surgery. It includes two groups: people with locally advanced cancer that has not spread, and those with limited spread (oligometastatic). The main goal is to see if the cancer disappears completely in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zanidatamab (a targeted antibody) combined with chemotherapy (oxaliplatin and capecitabine)
- What this could lead to
- If successful, this combination could help shrink HER2-positive stomach cancers before surgery, potentially leading to better surgical outcomes and longer survival.
- What could go wrong
- This is a Phase 2 trial with a small number of participants. The treatment may cause side effects from chemotherapy and the antibody, and it is not yet proven to be better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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. Willing and able to provide written informed consent (ICF). 2. Histologically and radiologically (CT/MRI) confirmed gastric or gastroesophageal junction adenocarcinoma. * Neoadjuvant cohort: Clinical stage III (cT3-4aN+M0) or locally advanced unresectable (cT4bNany M0) assessed by MDT as not amenable to R0 resection, or technically resectable but with high-risk factors (e.g., bulky nodal fusion, invasion of critical structures). * Conversion cohort: Not amenable to direct surgery (e.g., invasion of adjacent organs or vessels) or with distant metastases, including liver metastases (C-GCLM type I and II), confirmed retroperitoneal lymph node metastases, or other single-organ metastases. 3. HER2-positive by IHC (3+; or 2+ with FISH testing). No time window restriction on FISH. 4. Age 18-75 years, male or female. 5. ECOG performance status 0-1; no contraindication to surgery. 6. Adequate organ function for successful abdominal surgery. 7. Life expectancy \>= 3 months. 8. Laboratory parameters within 7 days before enrollment: 1. WBC \> 4.0 x 10\^9/L and \< 15 x 10\^9/L; ANC \> 1.5 x 10\^9/L; Hb \>= 90 g/L; PLT \>= 100 x 10\^9/L. 2. Total bilirubin \<= 1.5 x ULN; AST and ALT \<= 2.5 x ULN. 3. Creatinine \<= 1.5 x ULN, or CrCl \> 60 mL/min (Cockcroft-Gault). 4. No anticoagulation: INR and aPTT \<= 1.5 x ULN. On stable anticoagulation: maintain stable dose. 9. Good compliance; able to complete protocol-specified examinations and specimen collection. 10. Female patients of childbearing potential must agree to contraception from ICF signing through at least 5 months after last dose and refrain from breastfeeding. Male patients must agree to contraception from first dose through at least 7 months after last dose. Exclusion Criteria: 1. Synchronous or metachronous malignancies of other organs, or recurrent disease. 2. Prior systemic therapy for gastric cancer (neoadjuvant cohort). 3. History of malignancy within 5 years before screening, except those with \> 90% 5-year overall survival. 4. Significant cardiopulmonary dysfunction. 5. Major surgery within 4 weeks before study treatment initiation, or anticipated major surgery during study period (excluding diagnostic procedures). 6. Severe infection within 4 weeks before study treatment initiation. 7. Prior chemotherapy or molecular targeted therapy (neoadjuvant cohort). 8. Known hypersensitivity to study drugs or excipients, or history of severe allergic reactions to monoclonal antibodies. 9. Factors affecting oral medication intake (e.g., dysphagia \>= grade 2, chronic diarrhea). 10. Significant uncontrolled comorbidities that may affect protocol compliance or interpretation of outcomes. 11. Pregnancy or breastfeeding, or planning pregnancy during the study. 12. Diagnosis of immunodeficiency or receiving systemic corticosteroid (\> 10 mg/day prednisone equivalent) or other immunosuppressive therapy within 2 weeks before first dose. 13. Active hepatitis B (HBV DNA \>= 1 x 10\^3 copies/mL or \>= 200 IU/mL), positive anti-HCV, or positive HIV. 14. Participation in another anti-tumor clinical trial within 28 days before first dose. 15. Any condition that in the investigator's judgment may lead to premature study termination (e.g., serious illness including psychiatric disorders requiring concomitant treatment, severe laboratory abnormalities, family/social factors affecting subject safety or data collection). 16. Patient or family refusal to sign informed 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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, China
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