NCT06597227Recruiting
Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
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
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 404 (estimated)
- First submitted
- 5 Sept 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Guihua Wang
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06597227
What you commit to
- Study type: Interventional
- Planned participants: 404
- From 1 Mar 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- To be eligible to participate in this study, all patients must meet all the following criteria:
- The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
- Age 18-75 years old (at the time of signing the informed consent), both male and female;
- 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;
- Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
- ECOG score 0-1;
- Expected survival ≥6 months;
- Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
- The major organs function well and meet the following criteria:
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- 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;
- 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;
- Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
- 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.
Who the study is looking for
- To be eligible to participate in this study, all patients must meet all the following criteria:
- The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
- Age 18-75 years old (at the time of signing the informed consent), both male and female;
- 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;
- Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
- ECOG score 0-1;
- Expected survival ≥6 months;
- Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
- The major organs function well and meet the following criteria:
- <!-- -->
- 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;
- 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;
- Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.