A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer

K202309-06

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.

2023-08-01

2025-07-31

2025-07-31

Recruiting

Early phase I

60

Inclusion Criteria: 1. Age 18 or older, no gender limitation; 2. Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer; 3. Expected survival of ≥ 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. At least one measurable lesion outside the stomach (RECIST 1.1); 6. Patients informed about the purpose and course of the study and provided a written consent to participate. Exclusion Criteria: 1. Use of taurine agent within 1 month prior to randomization on this study; 2. Patients received prior systemic therapy for gastric cancer; 3. Patients with operable gastric cancer; 4. Patients with positive HER-2 and willing to receive herceptin treatment; 5. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia; 6. Patients with active autoimmune disease that has required systemic treatment in past 2 years; 7. Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy; 8. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group; 9. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator; 10. Other conditions that the investigator thinks are not suitable to participate in this clinical trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-11-08