Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
NCT06123455 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-11-08
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Taurine
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
- BIOLOGICAL
-
Sintilimab
Sintilimab
- DRUG
-
XELOX regimen
Oxaliplatin + capecitabine
- DRUG
-
SOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
- DRUG
-
FOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil
Sponsors & Collaborators
-
Tang-Du Hospital
lead OTHER
Principal Investigators
-
Xin Wang, MD, PhD · Tang-Du Hospital
-
Xiaodi Zhao, MD, PhD · Xi-Jing Hospital
-
Yuanyuan Lu, MD, PhD · Xi-Jing Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2025-07-31
- Completion
- 2025-07-31
Countries
- China
Study Locations
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