New hope for stomach cancer: adding surgery to drug therapy may improve outcomes
NCT ID NCT06468280
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with stomach cancer that has spread to a few other places in the body. It tests whether adding surgery and other local treatments to a combination of immunotherapy and chemotherapy helps people live longer without the cancer getting worse. About 84 adults will take part and be randomly assigned to get either drug therapy alone or drug therapy plus surgery.
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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 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- 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 79 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. Men or women aged 18-79. 2. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status. 3. Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers. 4. Primary gastric cancer lesions are resectable, with limited distant metastases meeting the either of the following criteria: (1) condition (a) only; (2) any single condition from (b), with or without (a). (a) Non-regional intra-abdominal lymph node metastasis: Include metastasis to the superior mesenteric artery, middle colic artery, and para-aortic/retroperitoneal nodes (according to AJCC 8th edition standards). (b1) Localized peritoneal metastasis: P0CY1, P1a, or P1b, according to the Japanese Classification of Gastric Carcinoma (15th edition). (b2) Liver metastasis: Up to 5 metastatic lesions. (b3) Lung metastasis: Up to 5 unilateral metastatic lesions. (b4) Ovarian metastasis: Unilateral or bilateral. (b5) Adrenal metastasis: Unilateral or bilateral. (b6) Single-region extra-abdominal lymph node metastasis: Such as cervical, supraclavicular, or mediastinal lymph nodes. (b7) Bone metastasis limited to a single radiation field. (b8) Other limited metastases as determined by the research team. 5. No previous anti-tumor treatments. 6. ECOG score ≤2, no surgical contraindications. 7. Life expectancy ≥ 3 months. 8. Physical condition and organ function suitable for major abdominal surgery. 9. Willingness and ability to comply with the study protocol. 10. Fertile women with a negative urine or serum pregnancy test and agreement to use effective contraception during the study and for 180 days after the last dose. Non-sterilized men must also agree to use effective contraception. 11. Signed informed consent with an understanding that patients can withdraw anytime. Exclusion Criteria: 1. Inability to tolerate oral chemotherapy. 2. Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis. 3. Central nervous system metastasis and/or carcinomatous meningitis. 4. Allergy to any components of the study medication. 5. History of previous malignancies or concurrent other malignancies, with the exception of completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, and other tumors with no recurrence for at least 5 years. 6. Uncontrolled pleural effusion, pericardial effusion, or ascites. 7. Weight loss ≥20% within two months before enrollment. 8. Upper gastrointestinal obstruction or physiological dysfunction. 9. Previous cytotoxic chemotherapy, radiotherapy, immunotherapy, or curative surgery. 10. Prior PD-1/PD-L1/PD-L2 or other T-cell-targeting therapy. 11. Systemic steroid or immunosuppressant use within 14 days before enrollment. 12. Live vaccine within four weeks prior to enrollment. 13. Uncontrolled systemic disease. 14. Active or past autoimmune diseases that may recur. 15. Severe chronic infections or active infections requiring systemic antibacterial, antifungal, or antiviral treatment. 16. History of lung disease. 17. Pregnancy, lactation, or planning for pregnancy. 18. HBsAg-positive with HBV DNA ≥500 IU/mL. 19. Positive HIV antibody. 20. Conditions that may impact study compliance or participation.
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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
2 sites. 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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Zhongshan Hospital Fudan University
NOT_YET_RECRUITINGShanghai, Shanghai City, 200032, China
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Zhongshan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, 201000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a personalized menu keep cancer patients stronger through chemotherapy?
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer