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RECRUITING
NCT06128252
NA

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

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2024-09-01

Completion Date

2027-06-30

Last Updated

2026-06-09

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

Taurine

Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

BIOLOGICAL

Serplulimab

Serplulimab

DRUG

XELOX regimen

Oxaliplatin + capecitabine

DIETARY_SUPPLEMENT

Placebo

Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

Locations (15)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Xi-jing Hospital

Xi'an, Shaanxi, China

Tang-Du Hospital

Xi'an, Shaanxi, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Xi 'an International Medical Center Hospital

Xi'an, Shaanxi, China

The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)

Xi'an, Shaanxi, China

Xi'an NO.3 hospital

Xi'an, Shaanxi, China

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Cancer Hospital Affiliated to Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, China

The First Affiliated Hospital of Army Medical University (Southwest Hospital)

Chongqing, China

Army Specialty Medical Center of PLA (Daping Hospital)

Chongqing, China

Fudan University Shanghai Cancer Center (FUSCC)

Shanghai, China