Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

Sponsor
Tang-Du Hospital
Study ID
NCT06128252
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Taurine — DIETARY_SUPPLEMENT
    Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
  • Serplulimab — BIOLOGICAL
    Serplulimab
  • XELOX regimen — DRUG
    Oxaliplatin + capecitabine
  • Placebo — DIETARY_SUPPLEMENT
    Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Taurine + Serplulimab + XELOX
    Taurine + Serplulimab + XELOX chemotherapy regimen
  • Active Comparator: Placebo + Serplulimab + XELOX
    Taurine placebo + Serplulimab + XELOX chemotherapy regimen

Primary Outcome Measure

Pathological complete response [ Time Frame: Through study completion, Within 1 week after operation ]

Central Contacts

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