Which surgery is better for advanced stomach cancer after Chemo-Immunotherapy?
NCT ID NCT06597227
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of stomach surgery (partial vs. total removal) for people with advanced upper gastric cancer who have already received chemotherapy combined with an immunotherapy drug. The goal is to see which surgery leads to better long-term outcomes, such as preventing cancer from coming back. About 404 participants will be randomly assigned to one of the two surgeries.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 404 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 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 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.
Inclusion Criteria: * To be eligible to participate in this study, all patients must meet all the following criteria: 1. The subjects voluntarily joined the study and were able to sign the informed consent with good compliance; 2. Age 18-75 years old (at the time of signing the informed consent), both male and female; 3. Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable; 4. Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy; 5. ECOG score 0-1; 6. Expected survival ≥6 months; 7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis; 8. The major organs function well and meet the following criteria: <!-- --> 1. Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L; 2. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min; 3. Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN; 4. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%; 5. Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects. Exclusion Criteria: * To be eligible to participate in this study, all patients must meet all the following criteria: 1. The subjects voluntarily joined the study and were able to sign the informed consent with good compliance; 2. Age 18-75 years old (at the time of signing the informed consent), both male and female; 3. Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable; 4. Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy; 5. ECOG score 0-1; 6. Expected survival ≥6 months; 7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis; 8. The major organs function well and meet the following criteria: <!-- --> 1. Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L; 2. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min; 3. Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN; 4. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%; 5. Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.
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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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Tongji Hospital, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430030, China
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Other studies related to the condition(s) this trial covers.
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- Precision radiation and immunotherapy join forces against inoperable stomach cancer
- AI could predict which stomach cancer patients benefit from Pre-Surgery therapy