Comparing two surgical methods for advanced gastric cancer after chemotherapy
Official title: Comparison of Clinical Efficacy of Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After SOX Combined With Anti-PD-1 Neoadjuvant Therapy:a Prospective, Multi-center, Randomised,Controlled Trial
Run by Tongji Hospital · NCT06597227 · Data updated 2026-11-12
This study is testing whether a less extensive stomach surgery can help people with advanced gastric cancer live longer and feel better after chemotherapy compared to a more complete surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 404 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2028 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT06597227 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with histologically confirmed locally advanced upper gastric adenocarcinoma who have not received prior systemic treatment.
✕Probably not a fit
Patients with distant metastasis or those who have undergone prior treatment for gastric cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy and safety of proximal radical gastrectomy versus total radical gastrectomy in patients with locally advanced upper gastric cancer who have undergone neoadjuvant therapy with SOX and anti-PD-1. The aim is to determine if preserving some gastric lymph nodes through proximal resection can enhance immunotherapy effectiveness and improve long-term survival and quality of life. The study will also investigate the predictive value of PD-L1 K162 methylation levels for immunotherapy sensitivity. Patients will be monitored for overall survival and postoperative outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with advanced gastric cancer.
How similar studies have gone: Previous studies have shown promising results with neoadjuvant therapies in gastric cancer, but this specific comparison of surgical methods is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Guihua Wang
- Email: ghwang@tjh.tjmu.edu.cn
- Phone: +86-027-83665215
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
HIPEC-primed therapy with serplulimab plus SOX/XELOX for locally advanced gastric cancer
This study tests a HIPEC-priming approach followed by PD-1 blocker–based chemotherapy to see if it helps people with locally advanced gastric cancer who have not yet spread.
-
Personalized ultrafractionated radiation plus immunotherapy for unresectable stomach cancer
This study tests, in patients with unresectable locally advanced stomach cancer who have not progressed after initial therapy, whether adding PULSAR radiation to ongoing systemic treatment improves control of the tumor.
-
AI-based prediction of who will respond to pre-surgery immunotherapy in locally advanced gastric cancer
A real-world study will test whether an AI system can predict which patients with locally advanced gastric cancer will respond to neoadjuvant chemotherapy plus PD-1 inhibitors before surgery.
-
Robotic surgery for advanced gastric cancer
This study is testing if robotic surgery can safely help people with advanced stomach cancer by reducing blood loss and hospital stays compared to traditional methods.
-
Comparing two types of lymphadenectomy after chemotherapy for stomach cancer
This study is testing whether a more extensive type of surgery for stomach cancer after chemotherapy can help patients do better than the standard surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.