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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological, Dietary supplement, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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);

• There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors;

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

• Patients informed about the purpose and course of the study and provided a written consent to participate.

Locations
Other Locations
China
Shaanxi Provincial People's Hospital
RECRUITING
Xi'an
Tang-Du Hospital
RECRUITING
Xi'an
The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
RECRUITING
Xi'an
Xi 'an International Medical Center Hospital
RECRUITING
Xi'an
Xi-jing Hospital
RECRUITING
Xi'an
Xi'an NO.3 hospital
RECRUITING
Xi'an
Contact Information
Primary
Xiaodi Zhao, MD, PhD
leedyzhao@fmmu.edu.cn
17702979587
Backup
Xin Wang, MD, PhD
wangx@fmmu.edu.cn
13571826689
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 96
Treatments
Experimental: Taurine + Serplulimab + XELOX
Taurine + Serplulimab + XELOX chemotherapy regimen
Active_comparator: Placebo + Serplulimab + XELOX
Taurine placebo + Serplulimab + XELOX chemotherapy regimen
Related Therapeutic Areas
Sponsors
Leads: Tang-Du Hospital

This content was sourced from clinicaltrials.gov