Comparing two surgical methods for advanced gastric cancer after chemotherapy

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 404 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: immunotherapy, chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06597227 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed locally advanced upper gastric adenocarcinoma who have not received prior systemic treatment.

Not a fit: Patients with distant metastasis or those who have undergone prior treatment for gastric cancer may not benefit from this study.

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 performed: Previous studies have shown promising results with neoadjuvant therapies in gastric cancer, but this specific comparison of surgical methods is novel.

Eligibility 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:

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  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:

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  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 this trial is running

Wuhan, Hubei

• Tongji Hospital, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Guihua Wang

Conditions Locally Advanced Gastric Cancer; Locally advanced gastric cancer; neoadjuvant chemotherapy; immunotherapy; Proximal radical gastrectomy; total radical gastrectomy