Actively Recruiting
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
Led by Guihua Wang · Updated on 2026-04-27
404
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
G
Guihua Wang
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the effectiveness and safety of two surgical methods, proximal gastric radical resection and total gastric radical resection, for patients with locally advanced upper gastric cancer. It focuses on patients who receive SOX chemotherapy combined with anti-PD-1 immunotherapy before surgery. The study aims to improve survival rates and quality of life by comparing these surgical options and exploring a new biomarker to predict response to immunotherapy. Participants first undergo 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After evaluating tumor response, those with partial or complete response and meeting criteria for proximal gastrectomy are randomly assigned to receive either proximal radical gastrectomy or total radical gastrectomy. Both groups continue with 4 cycles of SOX plus anti-PD-1 as adjuvant therapy after surgery, with anti-PD-1 treatment lasting one year. During the study, participants will be monitored for up to 3 years after surgery to assess disease-free survival, adverse events, nutritional status, and quality of life. Additional outcomes include pathologic response, resection success, and overall survival up to 5 years. The trial involves imaging, laboratory tests, and clinical evaluations to support treatment decisions and measure long-term effects.
CONDITIONS
Brief Title
Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years with signed informed consent and good compliance
- Confirmed diagnosis of locally advanced upper gastric carcinoma (adenocarcinoma) as per AJCC Edition 8 criteria, cT3-4 or N+M0
- No prior systemic treatment for current gastric cancer including chemotherapy, radiotherapy, or immunotherapy
- ECOG performance status of 0 or 1
- Expected survival of at least 6 months
- No distant metastasis confirmed by chest, abdominal, pelvic CT or PET-CT
- Adequate major organ function including blood counts, liver, kidney, coagulation, and heart function as assessed by doctors
- Fertile participants must use contraception during study and for 120 days after, have a negative pregnancy test before enrollment, and be non-lactating
You will not qualify if you...
- Patients unable or unwilling to sign informed consent or comply with study requirements
- Age below 18 or above 75 years
- Presence of distant metastasis or unresectable tumor
- Prior systemic anti-tumor treatment for current disease
- Poor performance status with ECOG score above 1
- Expected survival less than 6 months
- Inadequate organ function as shown by blood tests or heart evaluation
- Pregnancy or lactation without adherence to contraception and testing requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo assessments including imaging and lab tests to confirm eligibility.
Duration - Approximately 8 to 12 weeks
Participants receive 4 cycles of SOX chemotherapy combined with anti-PD-1 immunotherapy before surgery.
Visits occur for each chemotherapy cycle and immunotherapy administration.
Duration - Hospital stay duration typical for surgery and immediate recovery
Participants undergo either proximal radical gastrectomy or total radical gastrectomy based on random assignment after neoadjuvant therapy response evaluation.
1 surgical procedure with hospitalization
Duration - Up to 1 year
Participants receive 4 cycles of SOX chemotherapy combined with anti-PD-1 immunotherapy continuing for up to 1 year after surgery.
Regular visits for chemotherapy and immunotherapy administration during adjuvant treatment
Duration - Up to 5 years
Participants are monitored for disease-free survival, overall survival, nutritional status, quality of life, and adverse events for up to 3 to 5 years after surgery.
Periodic visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
G
Guihua Wang
L
lisheng chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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