A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.

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

• Age 18 or older, no gender limitation;

• Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;

• Expected survival of ≥ 3 months;

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

• At least one measurable lesion outside the stomach (RECIST 1.1);

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

Locations
Other Locations
China
Tang-Du 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: 2023-08-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Taurine + Sintilimab + investigator's choice chemotherapy
Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
Active_comparator: Sintilimab + investigator's choice chemotherapy
Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX
Related Therapeutic Areas
Sponsors
Leads: Tang-Du Hospital

This content was sourced from clinicaltrials.gov

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