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

NCT06128252 | Recruiting

• 1 other identifier: K202308-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

Taurine; neoadjuvant immunotherapy and chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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, Within 1 week after operation

Secondary Outcomes (10)

• R0 resection rate

  Through study completion, Within 1 week after operation

• Major pathological response (MPR)

  Through study completion, Within 1 week after operation

• Objective response rate (ORR)

  Through study completion, an average of 1 year.

• Disease-free survival (DFS)

  Through study completion, an average of 1 year

• Event-free survival (EFS)

  Through study completion, an average of 1 year

Study Arms (2)

Taurine + Serplulimab + XELOX

EXPERIMENTAL

Taurine + Serplulimab + XELOX chemotherapy regimen

Dietary Supplement: Taurine; Biological: Serplulimab; Drug: XELOX regimen

Placebo + Serplulimab + XELOX

ACTIVE COMPARATOR

Taurine placebo + Serplulimab + XELOX chemotherapy regimen

Biological: Serplulimab; Drug: XELOX regimen; Dietary Supplement: Placebo

Interventions

Taurine DIETARY_SUPPLEMENT

Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

Taurine + Serplulimab + XELOX

Serplulimab BIOLOGICAL

Serplulimab

Placebo + Serplulimab + XELOX; Taurine + Serplulimab + XELOX

XELOX regimen DRUG

Oxaliplatin + capecitabine

Placebo + Serplulimab + XELOX; Taurine + Serplulimab + XELOX

Placebo DIETARY_SUPPLEMENT

Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

Placebo + Serplulimab + XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (6)

Xi-jing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Tang-Du Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

Xi 'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

RECRUITING

The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)

Xi'an, Shaanxi, China

RECRUITING

Xi'an NO.3 hospital

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Taurine; XELOX

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: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, double-blind, randomized controlled clinical study.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 13, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CN (6)