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

NCT06123455 | Unknown Phase 2

• 1 other identifier: K202309-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Overall survival (OS)

  OS was defined as the time from randomization to death due to any cause.

  Up to 24 months

Secondary Outcomes (2)

• Objective response rate (ORR)

  Up to 24 months

• Safety profile

  Up to 24 months

Other Outcomes (2)

• Changes in CD8+ T cell death and function

  Up to 24 months

• Changes in CD8+ T cell infiltration in tumor tissue

  Up to 24 months

Study Arms (2)

Taurine + Sintilimab + investigator's choice chemotherapy

EXPERIMENTAL

Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX

Dietary Supplement: Taurine; Biological: Sintilimab; Drug: XELOX regimen; Drug: SOX regimen; Drug: FOLFOX regimen

Sintilimab + investigator's choice chemotherapy

ACTIVE COMPARATOR

Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX

Biological: Sintilimab; Drug: XELOX regimen; Drug: SOX regimen; Drug: FOLFOX regimen

Interventions

Taurine DIETARY_SUPPLEMENT

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

Taurine + Sintilimab + investigator's choice chemotherapy

Sintilimab BIOLOGICAL

Sintilimab

Sintilimab + investigator's choice chemotherapy; Taurine + Sintilimab + investigator's choice chemotherapy

XELOX regimen DRUG

Oxaliplatin + capecitabine

Sintilimab + investigator's choice chemotherapy; Taurine + Sintilimab + investigator's choice chemotherapy

SOX regimen DRUG

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

Sintilimab + investigator's choice chemotherapy; Taurine + Sintilimab + investigator's choice chemotherapy

FOLFOX regimen DRUG

Oxaliplatin + leucovorin + fluorouracil

Sintilimab + investigator's choice chemotherapy; Taurine + Sintilimab + investigator's choice chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tang-Du Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Taurine; sintilimab; XELOX; Folfox protocol

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Xin Wang, MD, PhD

  Tang-Du Hospital

  STUDY DIRECTOR

• Xiaodi Zhao, MD, PhD

  Xi-Jing Hospital

  PRINCIPAL INVESTIGATOR

• Yuanyuan Lu, MD, PhD

  Xi-Jing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodi Zhao, MD, PhD

CONTACT

17702979587; leedyzhao@fmmu.edu.cn

Xin Wang, MD, PhD

CONTACT

13571826689; wangx@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: November 8, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)