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Targeted antibody combo aims to shrink HER2-Positive stomach cancers before surgery

NCT ID NCT07685704

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Xijing Hospital, Air Force Medical University

    Xi'an, Shaanxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.