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

Phase 2

Recruiting

• Conditions: Gastric Cancer
• Interventions: Biological: Sintilimab; Dietary Supplement: Taurine; Drug: XELOX regimen; Drug: SOX regimen; Drug: FOLFOX regimen

• Registration Number: NCT06123455
• Lead Sponsor: Tang-Du Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-09-20
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age 18 or older, no gender limitation;
2. Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;
3. Expected survival of ≥ 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. At least one measurable lesion outside the stomach (RECIST 1.1);
6. Patients informed about the purpose and course of the study and provided a written consent to participate.

Exclusion Criteria

1. Use of taurine agent within 1 month prior to randomization on this study;
2. Patients received prior systemic therapy for gastric cancer;
3. Patients with operable gastric cancer;
4. Patients with positive HER-2 and willing to receive herceptin treatment;
5. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
6. Patients with active autoimmune disease that has required systemic treatment in past 2 years;
7. Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy;
8. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
9. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
10. Other conditions that the investigator thinks are not suitable to participate in this clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taurine + Sintilimab + investigator's choice chemotherapy	SOX regimen	Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
Sintilimab + investigator's choice chemotherapy	Sintilimab	Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX
Sintilimab + investigator's choice chemotherapy	SOX regimen	Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX
Sintilimab + investigator's choice chemotherapy	FOLFOX regimen	Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX
Taurine + Sintilimab + investigator's choice chemotherapy	Sintilimab	Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
Taurine + Sintilimab + investigator's choice chemotherapy	Taurine	Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
Taurine + Sintilimab + investigator's choice chemotherapy	XELOX regimen	Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
Sintilimab + investigator's choice chemotherapy	XELOX regimen	Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX
Taurine + Sintilimab + investigator's choice chemotherapy	FOLFOX regimen	Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 24 months	OS was defined as the time from randomization to death due to any cause.
Progression-free survival (PFS)	Up to 24 months	PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 24 months	ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Safety profile	Up to 24 months	Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

Trial Locations

Locations (1)

Tang-Du Hospital; 🇨🇳 Xi'an, Shaanxi, China