Taurine
Dietary SupplementTaurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
NCT Number: NCT06128252
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Serplulimab
Oxaliplatin + capecitabine
Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Time frame: Through study completion, Within 1 week after operation
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
The surgical margin is microscopically-negative for residual tumor.
Time frame: Through study completion, Within 1 week after operation
Residual tumor cells below 10% in the resected specimen.
Time frame: Through study completion, an average of 1 year.
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
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
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
OS 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]
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: 1 year
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: Through study completion, an average of 1 year
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
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.
Contact information is provided by the study sponsor or research team.
Xiaodi Zhao, MD, PhD
CONTACT
Xin Wang, MD, PhD
CONTACT
Tang-Du Hospital
Other
A Prospective, Multicentre, Double-blind Randomized Controlled Clinical Study of the Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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