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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Tongji Hospital, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Guihua Wang
ghwang@tjh.tjmu.edu.cn
+86-027-83665215
Backup
lisheng chen
clsmail1990@163.com
+86-13797056427
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 404
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Air Force Medicial University, Jingzhou Central Hospital, Ruijin Hospital, Southern Medical University, China, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Medical Center of Chinese PLA General Hospital, The Third Xiangya Hospital of Central South University, First Affiliated Hospital, Sun Yat-Sen University, Xiangya Hospital of Central South University, Affiliated Hospital of Qinghai University, Qilu Hospital of Shandong University, The First affiliated Hospital of Shandong Second Medical University, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanxi Bethune Hospital, The First Affiliated Hospital of University of South China, Fujian Medical University Union Hospital, People's Hospital of Macheng City, Zhongnan Hospital, Xiangyang Central Hospital, Yichang Central People's Hospital
Leads: Guihua Wang

This content was sourced from clinicaltrials.gov