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

A Prospective, 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: Gastric Cancer
• Intervention / Treatment: Dietary supplement: Taurine; Drug: XELOX regimen; Biological: Serplulimab; Drug: FLOT regimen

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaodi Zhao, MD, PhD; Phone Number: 17702979587; Email: leedyzhao@fmmu.edu.cn
• Study Contact Backup: Name: Xin Wang, MD, PhD; Phone Number: 13571826689; Email: wangx@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tang-du Hospital
      • Contact: Xin Wang, MD, PhD; Phone Number: 13571826689; Email: wangx@fmmu.edu.cn
      • Contact: Jia Yu, MD; Phone Number: 1862928617; Email: yj1862928617@163.com

Participation Criteria

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;
3. Expected survival of ≥ 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. 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 and willing to receive herceptin treatment;
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. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
6. Other conditions that the investigator thinks are not suitable to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taurine + Serplulimab + investigator's choice chemotherapy; Taurine + Serplulimab + XELOX or Taurine + Serplulimab + FLOT	Dietary supplement: Taurine; Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.; Drug: XELOX regimen; Oxaliplatin + capecitabine; Biological: Serplulimab; Serplulimab; Drug: FLOT regimen; Fluorouracil + leucovorin + oxaliplatin + docetaxel
Active Comparator: Serplulimab + investigator's choice chemotherapy; Serplulimab + XELOX or Serplulimab + FLOT	Drug: XELOX regimen; Oxaliplatin + capecitabine; Biological: Serplulimab; Serplulimab; Drug: FLOT regimen; Fluorouracil + leucovorin + oxaliplatin + docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response	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, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	The surgical margin is microscopically-negative for residual tumor.	Through study completion, an average of 1 year
Major pathological response (MPR)	Residual tumor cells below 10% in the resected specimen.	Through study completion, an average of 1 year
Disease-free survival (DFS)	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)	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)	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	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	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	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

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Taurine; neoadjuvant immunotherapy and chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• 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