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Tailored therapy after stomach cancer surgery could boost survival

NCT ID NCT07603349

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether changing the type of chemotherapy after stomach cancer surgery can help people live longer. It involves 405 adults who had chemotherapy and immunotherapy before surgery. Depending on how much cancer remained after surgery, some will get a different treatment, while others may not need any further treatment. The goal is to see if personalizing care improves outcomes.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 405 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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.

Key Inclusion Criteria: 1. Voluntarily signed written informed consent. 2. Aged 18 to 75 years, inclusive, regardless of sex. 3. Underwent radical gastrectomy with D2 or more extended lymphadenectomy and achieved R0 resection. Surgical approaches may include open or laparoscopic surgery. 4. Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma. 5. Received preoperative neoadjuvant immunotherapy combined with chemotherapy, including oxaliplatin plus fluoropyrimidine-based chemotherapy. Immunotherapy may include anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, PD-1/CTLA-4 bispecific antibodies, and other immune checkpoint inhibitors. 6. Eligible for one of the following predefined cohorts: * Cohort 1: TRG grade 3 and postoperative pathological stage ypT3-4N2-3M0. * Cohort 2: TRG grade 0 and postoperative pathological stage ypT0N0M0. 7. ECOG performance status of 0 or 1. 8. No evidence of metastasis or recurrence on postoperative imaging before enrollment. 9. Adequate organ function, defined as hematologic, hepatic, renal, and thyroid function meeting the protocol-specified criteria based on laboratory tests performed within 14 days before randomization. 10. Willing and able to comply with the study treatment, scheduled visits, laboratory tests, and other study procedures. 11. Female participants of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of study treatment. Key Exclusion Criteria: 1. Presence of liver, peritoneal, or other distant metastases. 2. Inability to take oral medications. 3. Unresolved postoperative complications at the time of randomization, such as postoperative infection, anastomotic leakage or wound dehiscence, gastrointestinal bleeding, pancreatic fistula, or intestinal obstruction. 4. Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites at screening, defined as any of the following: pleural effusion or ascites with clinical symptoms and detectable by physical examination; or pleural effusion or ascites requiring drainage and/or intracavitary treatment during screening. 5. Underwent any surgery requiring general anesthesia that was not related to gastric cancer within 28 days before randomization. 6. History of or current diagnosis of another malignancy within 5 years. 7. Active or prior autoimmune disease that may relapse or require immunosuppressive treatment within 2 weeks or during the study period; or a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disease; or a history of organ transplantation. 8. Participation in another clinical study, or any condition that may interfere with the interpretation of the study results. 9. Any other severe acute or chronic disease that, in the investigator's judgment, may increase the risk associated with study participation or study treatment. 10. Active or uncontrolled infection requiring systemic antibiotic therapy within 2 weeks before randomization or at the time of randomization. 11. Diagnosis of interstitial pneumonia, noninfectious pneumonitis, pulmonary fibrosis, or acute lung disease. 12. Active tuberculosis within 1 year or previous anti-tuberculosis treatment. 13. Female participants who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after the end of treatment. 14. History of psychotropic drug abuse with inability to discontinue, or presence of a psychiatric disorder. 15. Patients considered unsuitable for participation in this study by the investigator.

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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

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, China

More trials for these conditions

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