Status:
UNKNOWN
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
Lead Sponsor:
Tang-Du Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 achievin...
Eligibility Criteria
Inclusion
- 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
- 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;
- Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
- Other conditions that the investigator thinks are not suitable to participate in this clinical trial.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06123455
Start Date
August 1 2023
End Date
July 31 2025
Last Update
November 8 2023
Active Locations (1)
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1
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038