Tailored therapy after stomach cancer surgery could boost survival
NCT ID NCT07603349
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 405 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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 75 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.
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.
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The places running it
1 site. 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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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One small incision vs several: robotic stomach cancer surgery put to the test
- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a vaccine stop GI cancers from returning?
- Blood test aims to catch Cancer's return earlier