Status:
RECRUITING
Proximal Gastrectomy Vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
Lead Sponsor:
Guihua Wang
Collaborating Sponsors:
Fudan University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Locally Advanced Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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
Detailed Description
Gastric cancer is one of the most common malignant tumors in China, and its morbidity and mortality rank among the top three for a long time.How to improve the survival rate of patients with advanced ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT06597227
Start Date
March 1 2024
End Date
December 30 2028
Last Update
September 19 2024
Active Locations (1)
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1
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030