Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gas… (NCT06123455) | Clinical Trial Compass
UnknownPhase 2
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
China60 participantsStarted 2023-08-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 or older, no gender limitation;
✓. Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;
✓. Expected survival of ≥ 3 months;
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
✓. At least one measurable lesion outside the stomach (RECIST 1.1);
✓. Patients informed about the purpose and course of the study and provided a written consent to participate.
Exclusion criteria
✕. Use of taurine agent within 1 month prior to randomization on this study;
✕. Patients received prior systemic therapy for gastric cancer;
✕. Patients with operable gastric cancer;
✕. Patients with positive HER-2 and willing to receive herceptin treatment;
✕. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
✕. Patients with active autoimmune disease that has required systemic treatment in past 2 years;
✕. Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy;
✕. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;