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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123455
• Other study ID #: K202309-06
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: Tang-Du Hospital
• Contact: Xiaodi Zhao, MD, PhD
• Phone: 17702979587
• Email: leedyzhao[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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
• SOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
• FOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil

Locations

Country	Name	City	State
China	Tang-Du Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in CD8+ T cell death and function	Changes in number, apoptosis rate, effector (TNF-a, IFN-?, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.	Up to 24 months
Other	Changes in CD8+ T cell infiltration in tumor tissue	Changes in number, effector (TNF-a, IFN-?, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy material assessed via immunohistochemistry.	Up to 24 months
Primary	Progression-free survival (PFS)	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.	Up to 24 months
Primary	Overall survival (OS)	OS was defined as the time from randomization to death due to any cause.	Up to 24 months
Secondary	Objective response rate (ORR)	ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.	Up to 24 months
Secondary	Safety profile	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.	Up to 24 months