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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-75 years old, no gender limitation;

Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III,T≥3, N ≥0, M=0;

Expected survival of ≥ 3 months;

The tumor specimens were PD-L1 positive (CPS ≥ 1);

Disqualifiers

Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;

Patients with positive HER-2;

Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;

Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;

Trial design

Treatments tested in this trial

  • Taurine
  • Serplulimab
  • XELOX regimen
  • Placebo

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators