Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

NCT06123455 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-08

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Taurine

Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.

BIOLOGICAL

Sintilimab

Sintilimab

DRUG

XELOX regimen

Oxaliplatin + capecitabine

DRUG

SOX regimen

Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)

DRUG

FOLFOX regimen

Oxaliplatin + leucovorin + fluorouracil

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Principal Investigators

  • Xin Wang, MD, PhD · Tang-Du Hospital

  • Xiaodi Zhao, MD, PhD · Xi-Jing Hospital

  • Yuanyuan Lu, MD, PhD · Xi-Jing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06123455 on ClinicalTrials.gov