This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Serplulimab
Oxaliplatin + capecitabine
Xi-jing Hospital
Xi'an, Shaanxi, China
RECRUITINGTang-Du Hospital
Xi'an, Shaanxi, China
RECRUITINGShaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Pathological complete response
To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.
Time frame: Through study completion, Within 1 week after operation
R0 resection rate
The surgical margin is microscopically-negative for residual tumor.
Time frame: Through study completion, Within 1 week after operation
Major pathological response (MPR)
Residual tumor cells below 10% in the resected specimen.
Time frame: Through study completion, Within 1 week after operation
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: Through study completion, an average of 1 year.
Disease-free survival (DFS)
DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence.
Time frame: Through study completion, an average of 1 year
Event-free survival (EFS)
EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence.
Time frame: Through study completion, an average of 1 year
Overall survival (OS)
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Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Xi 'an International Medical Center Hospital
Xi'an, Shaanxi, China
RECRUITINGThe Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Xi'an, Shaanxi, China
RECRUITINGXi'an NO.3 hospital
Xi'an, Shaanxi, China
RECRUITINGOS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.
Time frame: Through study completion, an average of 1 year
Quality of life
The quality of life was assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-STO22 and Piper Fatigue Scale.
Time frame: Through study completion, an average of 1 year]
Changes in CD8+ T cell infiltration in tumor tissue
Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy or surgical resection material assessed via flow cytometry and immunohistochemistry.
Time frame: 1 year
Changes in CD8+ T cell death and function
Changes in number, apoptosis rate, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.
Time frame: Through study completion, an average of 1 year
Safety endpoints
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: Through study completion, an average of 1 year