Recruiting
Not applicable
Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
Condition(s) studied
Locally Advanced Gastric Cancer
Investigational drug(s) / intervention(s)
Proximal radical gastrectomyTotal radical gastrectomy
Proximal radical gastrectomy: Proximal radical gastrectomy : Dissection of lymph nodes No.1,2,3a,4sa,4sb,7,8a, 9, 11p, 11dare recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: double channel anastomosis is recommended, and other anastomosis methods can be carried out according to the surgeon\'s habit.
Total radical gastrectomy: total radical gastrectomy : Dissection of lymph nodes No.1-7, 8a, 9, 11p, 11d, 12a are recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: Roux⁃en⁃Y anastomosis is recommended
Study 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
Eligibility
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.
Primary outcome measure(s)
- 3-year Disease-free survival (DFS) — UP to 3 years after surgery
DFS is based on RECIST(Response Evaluation Criteria in Solid Tumours) 1.1 as assessed by the investigator and is defined as the time from surgery initiation to the date of first documentation of disease recurrence or death due to any cause
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Tongji Hospital, Huazhong University of Science and Technology |
Wuhan |
Hubei |
Recruiting |
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