Proximal Gastrectomy Vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
NCT ID: NCT06597227
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
404 participants
INTERVENTIONAL
2024-03-01
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Proximal radical gastrectomy group
Patients with locally advanced upper gastric cancer were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD (Progressive disease) and SD (Stable disease) patients were replaced with conservative treatment or surgical treatment after MDT (Multi-disciplinary Treatment) discussion; (2) For PR (Partial response) and CCR (Clinical complete response) patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, which were divided into experimental group : the group of proximal gastric radical surgery; Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year.
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 group
Patients with untreated, operable locally advanced upper gastric cancer who signed informed consent and met the screening criteria were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD and SD patients were replaced with conservative treatment or surgical treatment after MDT discussion; (2) For PR and CCR patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, Cohort 2 (control group) : total radical gastrectomy group. Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year.
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
Interventions
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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
Eligibility Criteria
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Inclusion 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
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.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
The First Affiliated Hospital of Air Force Medicial University
OTHER
Xiangya Hospital of Central South University
OTHER
The First affiliated Hospital of Shandong Second Medical University
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The First Medical Center of Chinese PLA General Hospital
OTHER
Affiliated Hospital of Qinghai University
OTHER
Qilu Hospital of Shandong University
OTHER
Ruijin Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Southern Medical University, China
OTHER
Zhongnan Hospital
OTHER
Shanxi Bethune Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Fujian Medical University Union Hospital
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Jingzhou Central Hospital
OTHER
Xiangyang Central Hospital
OTHER
Yichang Central People's Hospital
OTHER
People's Hospital of Macheng City
UNKNOWN
The First Affiliated Hospital of University of South China
OTHER
Guihua Wang
OTHER
Responsible Party
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Guihua Wang
Professor
Locations
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Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Tongji Hospital, Huazhong University of Science and Technology
Role: primary
Other Identifiers
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2024-S029
Identifier Type: -
Identifier Source: org_study_id
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