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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
Sintilimab
Oxaliplatin + capecitabine
Tang-Du Hospital
Xi'an, Shaanxi, China
RECRUITINGProgression-free survival (PFS)
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.
Time frame: Up to 24 months
Overall survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to 24 months
Objective response rate (ORR)
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Time frame: Up to 24 months
Safety profile
Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Time frame: Up to 24 months
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Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
Oxaliplatin + leucovorin + fluorouracil