Can a targeted drug duo boost the power of surgery for stomach cancer?

NCT ID NCT07802288

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether combining two targeted therapies, with or without chemotherapy, can improve outcomes for people with resectable stomach or gastroesophageal junction cancer. Participants receive the treatment before and after surgery to remove the tumor. The main goal is to see if the cancer disappears completely at the time of surgery, which could lead to better long-term results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trastuzumab rezetecan plus retlirafusp alfa, with or without CAPOX chemotherapy (oxaliplatin and capecitabine)
What this could lead to
If successful, this approach could shrink tumors before surgery and reduce the chance of cancer returning after surgery, potentially improving long-term survival for people with gastric cancer.
What could go wrong
This is an early-phase trial with a small number of participants. The combination may cause significant side effects, and the benefit over standard treatment is not yet proven.

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 80 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

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. Voluntarily sign written informed consent before any study-related procedures 2. Age ≥18 and ≤75 years old 3. Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma 4. AJCC 8th edition stage II-III resectable disease (cT1-2N+M0, T3-4aNanyM0); negative peritoneal cytology (CY0) confirmed by pre-study laparoscopy 5. HER2 expression status: High HER2 (IHC 3+ or IHC 2+ FISH-positive) OR Low/Intermediate HER2 (IHC 2+ FISH-negative / IHC 1+) 6. No prior systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy, radical gastrectomy) 7. Planned radical D2 gastrectomy after neoadjuvant treatment completion 8. Able to swallow oral capecitabine tablets intact 9. ECOG Performance Status 0 or 1 10. Estimated overall survival ≥12 months 11. Adequate organ function (no blood products/G-CSF within prior 14 days): * ANC ≥1.5×10⁹/L; PLT ≥80×10⁹/L; Hb ≥90 g/L * Total bilirubin \<1.5×ULN; ALT/AST ≤2.5×ULN * Serum Cr ≤1.5×ULN or CrCl \>50 mL/min * INR, PT, APTT ≤1.5×ULN 12. Fertile female subjects: Negative serum pregnancy test within 72 hours before first dose; all fertile participants agree to effective contraception during treatment and required post-treatment contraceptive window Exclusion Criteria: 1. Siewert type I GEJ tumor or Siewert II tumor requiring cervicothoracic surgical approach 2. Confirmed peritoneal metastasis, positive peritoneal cytology (CY1), or AJCC T4b disease 3. Tumor unresectable or absolute contraindication to radical gastrectomy 4. History of other malignant tumor within past 5 years (excluding cured basal cell skin carcinoma, cervical/breast carcinoma in situ) 5. Uncontrolled hypertension (SBP≥160 mmHg or DBP≥100 mmHg despite optimal medical management) 6. Cardiac dysfunction: NYHA grade ≥2 heart failure, LVEF \<50%, unstable angina, myocardial infarction within 1 year, prolonged QTc interval (male \>450ms, female \>470ms), family history of sudden cardiac death \<40 years old 7. GI perforation/fistula within 6 months, intestinal obstruction within 3 months (not fully resolved) 8. Active severe bleeding disorder or active peptic ulcer disease 9. Arterial/venous thromboembolic event within past 6 months (stroke, DVT, pulmonary embolism etc.) 10. Severe uncontrolled infection (≥CTCAE grade 2) within 4 weeks prior to first dose 11. Active viral hepatitis (HBV DNA ≥2000 IU/mL; active HCV viremia) or HIV positive 12. History or active interstitial lung disease, pulmonary fibrosis, active tuberculosis 13. Active autoimmune disease requiring long-term systemic immunosuppressive therapy 14. Systemic corticosteroid dose \>10 mg prednisone equivalent within 7 days pre-treatment 15. Received live attenuated vaccine within 28 days before enrollment 16. Hypersensitivity to any study drug or excipients 17. Participation in other interventional clinical trials within 4 weeks prior to first dose 18. Lactating female subjects 19. Any medical, psychiatric or social condition judged by investigator to interfere with study compliance or subject safety

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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

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000, China

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