Actively Recruiting
A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
Led by Fudan University · Updated on 2026-03-25
276
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.
CONDITIONS
Official Title
A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Male or female, age 18 years or older.
- Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
- Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry or microsatellite instability-high (MSI-H) by genetic sequencing.
- Underwent D2 or more extensive radical resection with R0 resection achieved.
- Able to swallow tablets normally.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 6 months.
- Adequate organ function meeting specified laboratory criteria including blood counts, liver and kidney function, coagulation, thyroid, and cardiac enzymes.
- For females of childbearing potential, a negative pregnancy test within 3 days prior to first dose.
- Use of effective contraception with failure rate less than 1% per year during treatment and for 120 days after last dose of study drug (or 180 days after last chemotherapy dose).
You will not qualify if you...
- Tumors involving the esophagogastric junction with the tumor center located in the proximal stomach within 2 cm of the junction.
- Diagnosis of any other malignant disease within 5 years prior to first dose, excluding certain skin cancers and carcinoma in situ.
- Participation in other interventional clinical studies or use of investigational drugs/devices within 4 weeks prior to first dose.
- Prior treatment with anti-PD-1, anti-PD-L1, or other immune checkpoint inhibitors.
- Recent use (within 2 weeks) of systemic anti-tumor Chinese patent medicines or immunomodulatory drugs.
- Active autoimmune disease requiring systemic treatment within 2 years prior to first dose.
- Systemic corticosteroid or immunosuppressive therapy within 7 days prior to first dose.
- History of organ transplantation except corneal transplantation.
- Known allergy to any study drug.
- Incomplete recovery from prior treatment toxicities above grade 1.
- Known HIV infection.
- Untreated active hepatitis B or active hepatitis C infection.
- Live vaccine received within 30 days prior to first dose.
- Pregnant or breastfeeding women.
- Severe or uncontrolled systemic diseases including significant heart conditions, unstable angina, recent thrombotic events, uncontrolled hypertension, lung disease, active infections, liver disease, poorly controlled diabetes, significant proteinuria, or mental disorders affecting compliance.
- Other conditions or abnormalities that may interfere with study participation or results as determined by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200230
Actively Recruiting
Research Team
X
Xiaowen Liu
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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