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

Locations

15
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology WuhanHubei, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University210008, NanjingJiangsu, China
The First Affiliated Hospital of China Medical University110001, ShenyangLiaoning, China
Shaanxi Provincial People's Hospital710068, Xi'anShaanxi, China

Sponsors and collaborators

Tang-Du Hospital

Lead sponsor