Actively Recruiting
A Phase II, Multicenter, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Sintilimab Plus SOX Versus SOX Alone as Adjuvant Therapy for PD-L1-Positive, Stage pN3 Gastric Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-04
460
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study intends to enroll gastric cancer patients who are PD-L1 positive and pathologically confirmed as Stage N3. Enrolled patients will be randomly assigned to receive either standard adjuvant SOX regimen or SOX regimen combined with sintilimab. The objective of the study is to determine whether adding a PD-1 inhibitor to postoperative chemotherapy can improve the Disease-Free Survival (DFS) rate in patients with Stage N3 gastric cancer.
CONDITIONS
Official Title
A Phase II, Multicenter, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Sintilimab Plus SOX Versus SOX Alone as Adjuvant Therapy for PD-L1-Positive, Stage pN3 Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Age between 18 and 75 years
- Radical resection with D2 or wider lymph node dissection and R0 resection status
- No prior systemic anti-tumor treatment before surgery
- Histopathologically confirmed gastric adenocarcinoma
- Pathological stage TxN3M0 per 8th edition AJCC Cancer Staging Manual
- PD-L1 Combined Positive Score (CPS) of 1 or higher
- ECOG Performance Status of 0 or 1
- Expected survival time of at least 6 months
- Adequate organ function based on specified laboratory criteria
- Negative pregnancy test within 3 days before first study drug administration for females of childbearing potential
- Use of effective contraception during treatment and for 120 days after last study drug dose
You will not qualify if you...
- Squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, neuroendocrine tumor, or gastrointestinal stromal tumor (except mixed carcinoma with adenocarcinoma >80%)
- Other malignant diseases within 5 years before first dose, except certain treated cancers
- Participation in other therapeutic clinical trials or other study drug use within 4 weeks before first dose
- Previous anti-PD-1, anti-PD-L1, or other T-cell receptor targeting therapies
- Recent use of Chinese patent medicines or immunomodulatory drugs by systemic treatment within 2 weeks
- Active autoimmune diseases requiring systemic treatment within 2 years
- Systemic glucocorticoid or immunosuppressive therapy within 7 days before first dose (physiological doses allowed)
- History of allogeneic organ or hematopoietic stem cell transplantation (except corneal)
- Allergy to study drugs
- Unresolved toxicity or complications from prior treatments
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccines within 30 days before first dose
- Pregnant or lactating women
- Severe or uncontrolled systemic diseases including significant heart conditions, recent arterial thrombosis, uncontrolled blood pressure, active lung disease, infections, liver disease, poorly controlled diabetes, or mental disorders preventing cooperation
- Other medical conditions or risks deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
H
Hao Xu, M.D & Ph.D
CONTACT
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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