A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy … (NCT07492615) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
China276 participantsStarted 2026-01-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent.
✓. Male or female, age ≥18 years.
✓. Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
✓. Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
✓. Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.
✓. Underwent D2 or more extensive radical resection and achieved R0 resection.
✓. Able to swallow tablets normally.
✓. ECOG performance status 0-1.
Exclusion criteria
✕. Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.
✕. Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ).
✕. Currently participating in interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to first dose.
✕. Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
✕. Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons, interleukins, except for local use to control pleural effusion) within 2 weeks prior to first dose.
✕. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.
✕. Receiving systemic corticosteroid therapy (excluding nasal spray, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to first dose.
✕. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.