Actively Recruiting
A Phase II, Multicenter, Randomized, Controlled Clinical Study Comparing 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with PD-L1-positive, Stage N3 gastric cancer who have undergone surgery. This Phase II study aims to find out if adding the PD-1 inhibitor sintilimab to the standard SOX chemotherapy regimen after surgery can improve the time patients remain free from cancer (Disease-Free Survival). The trial compares two groups to see if this combination therapy is more effective than chemotherapy alone. Participants are randomly assigned to one of two groups. One group receives 6 to 8 cycles of sintilimab combined with the SOX chemotherapy regimen, followed by continued sintilimab as maintenance treatment for up to one year. The other group receives 6 to 8 cycles of only the SOX chemotherapy regimen. The SOX regimen includes oral S-1 twice daily for 14 days and an intravenous infusion of oxaliplatin on Day 1, repeated every 21 days. Sintilimab is given intravenously every 21 days, with dosing based on body weight. Throughout the study, participants will be monitored regularly with assessments to measure outcomes such as Disease-Free Survival over 3 years, Overall Survival over 5 years, and the occurrence of side effects including serious adverse events. Safety and health will be closely observed during treatment and follow-up. The study is expected to last until October 2030, involving adult patients aged 18 to 75 years who meet specific medical and laboratory requirements.
CONDITIONS
Brief 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 informed consent before any study procedures
- Aged 18 to 75 years
- Underwent radical surgery with D2 or wider lymph node dissection and achieved R0 resection
- No prior systemic anti-tumor treatment before surgery
- Histopathologically confirmed gastric adenocarcinoma
- Pathological stage TxN3M0 according to AJCC 8th edition
- 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 meeting specific laboratory criteria
- Negative pregnancy test for women of childbearing potential before first study drug dose
- Use of effective contraception during treatment and for 120 days after last study drug dose
You will not qualify if you...
- Diagnosed with 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 skin and thyroid cancers)
- Participation in other therapeutic clinical trials or recent use of other study drugs
- Prior treatment with anti-PD-1, anti-PD-L1, or similar immune therapies
- Recent use of Chinese patent medicines or immunomodulatory drugs systemically
- History of active autoimmune diseases requiring systemic treatment within 2 years
- Recent systemic glucocorticoid or immunosuppressive therapy
- History of allogeneic organ or stem cell transplantation (except corneal)
- Known allergy to study drugs
- Incomplete recovery from prior treatment toxicities
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Recent live vaccine administration
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic diseases such as serious heart conditions, recent arterial thrombosis, uncontrolled blood pressure, active lung disease or infections, liver diseases, uncontrolled diabetes, or mental disorders interfering with treatment
- Other medical conditions or lab abnormalities that may interfere with study completion or safety as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year including maintenance
Participants receive 6 to 8 cycles of treatment with either sintilimab plus SOX chemotherapy or SOX chemotherapy alone. Those receiving sintilimab plus SOX will continue sintilimab as maintenance therapy for up to one year.
Treatments repeated every 21 days with multiple visits during cycles
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
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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