Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

January 5, 2025 updated by: Tang-Du Hospital

A Prospective, Multicentre, Double-blind Randomized Controlled Clinical Study of the Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi provincial people's hospital
        • Contact:
        • Principal Investigator:
          • Ruiting Liu, PhD
      • Xi'an, Shaanxi, China, 710038
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xi'an No.3 Hospital
        • Contact:
        • Principal Investigator:
          • Tongfei Wang, PhD
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xi-jing Hospital
        • Contact:
        • Principal Investigator:
          • Jipeng Li, PhD
        • Sub-Investigator:
          • Shichao Li, PhD
      • Xi'an, Shaanxi, China, 710100
        • Recruiting
        • Xi 'an International Medical Center Hospital
        • Contact:
        • Principal Investigator:
          • Qingchuan Zhao, PhD
      • Xi'an, Shaanxi, China
        • Recruiting
        • The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
        • Contact:
          • Zhidong Wang, PhD
          • Phone Number: 029-87679386
          • Email: xawzd@163.com
        • Principal Investigator:
          • Zhidong Wang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years old, no gender limitation;
  2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III，T≥3, N ≥0, M=0；
  3. Expected survival of ≥ 3 months;
  4. The tumor specimens were PD-L1 positive (CPS ≥ 1)；
  5. There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors；
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  7. 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 the first dose of study treatment and throughout the study;
  2. Patients with positive HER-2；
  3. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
  4. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
  5. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use；
  6. There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are not suitable for participating in the clinical study according to the judgment of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taurine + Serplulimab + XELOX
Taurine + Serplulimab + XELOX chemotherapy regimen
Drug: XELOX regimen
Oxaliplatin + capecitabine
Biological: Serplulimab
Serplulimab
Dietary supplement: Taurine
Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Active Comparator: Placebo + Serplulimab + XELOX
Taurine placebo + Serplulimab + XELOX chemotherapy regimen
Drug: XELOX regimen
Oxaliplatin + capecitabine
Biological: Serplulimab
Serplulimab
Dietary supplement: Placebo
Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response
Time Frame: Through study completion, Within 1 week after operation
To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.
Through study completion, Within 1 week after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: Through study completion, an average of 1 year
DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence.
Through study completion, an average of 1 year
Event-free survival (EFS)
Time Frame: Through study completion, an average of 1 year
EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence.
Through study completion, an average of 1 year
Overall survival (OS)
Time Frame: Through study completion, an average of 1 year
OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.
Through study completion, an average of 1 year
Changes in CD8+ T cell infiltration in tumor tissue
Time Frame: 1 year
Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy or surgical resection material assessed via flow cytometry and immunohistochemistry.
1 year
Changes in CD8+ T cell death and function
Time Frame: Through study completion, an average of 1 year
Changes in number, apoptosis rate, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.
Through study completion, an average of 1 year
Safety endpoints
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
R0 resection rate
Time Frame: Through study completion, Within 1 week after operation
The surgical margin is microscopically-negative for residual tumor.
Through study completion, Within 1 week after operation
Major pathological response (MPR)
Time Frame: Through study completion, Within 1 week after operation
Residual tumor cells below 10% in the resected specimen.
Through study completion, Within 1 week after operation
Objective response rate (ORR)
Time Frame: Through study completion, an average of 1 year.
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Through study completion, an average of 1 year.
Quality of life
Time Frame: Through study completion, an average of 1 year]
The quality of life was assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-STO22 and Piper Fatigue Scale.
Through study completion, an average of 1 year]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Director: Xin Wang, MD, PhD, Tang-Du Hospital
  • Principal Investigator: Xiaodi Zhao, MD, PhD, Xi-jing Hospital
  • Principal Investigator: Yuanyuan Lu, MD, PhD, Xi-jing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K202308-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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