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New hope for stomach cancer: adding surgery to drug therapy may improve outcomes

NCT ID NCT06468280

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 84 people

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

Started

Nov 2024

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 79 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. 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.

  1. The places running it

    2 sites. 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

  • Zhongshan Hospital Fudan University

    NOT_YET_RECRUITING

    Shanghai, Shanghai City, 200032, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201000, China

More trials for these conditions

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