Recruiting NCT06128252
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Taurine, Serplulimab, XELOX regimen, Placebo.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Dietary supplement Taurine
Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day. - Biological Serplulimab
Serplulimab - Drug XELOX regimen
Oxaliplatin + capecitabine - Dietary supplement Placebo
Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Primary outcome measures
- Pathological complete response [Time frame: Through study completion, Within 1 week after operation]
Secondary outcome measures (10)
- R0 resection rate [Time frame: Through study completion, Within 1 week after operation]
- Major pathological response (MPR) [Time frame: Through study completion, Within 1 week after operation]
- Objective response rate (ORR) [Time frame: Through study completion, an average of 1 year.]
- Disease-free survival (DFS) [Time frame: Through study completion, an average of 1 year]
- Event-free survival (EFS) [Time frame: Through study completion, an average of 1 year]
- Overall survival (OS) [Time frame: Through study completion, an average of 1 year]
- Quality of life [Time frame: Through study completion, an average of 1 year]]
- Changes in CD8+ T cell infiltration in tumor tissue [Time frame: 1 year]
- Changes in CD8+ T cell death and function [Time frame: Through study completion, an average of 1 year]
- Safety endpoints [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 15 centers
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and — Wuhan
- Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing
- The First Affiliated Hospital of China Medical University — Shenyang
- Xi-jing Hospital — Xi'an
- Tang-Du Hospital — Xi'an
- Shaanxi Provincial People's Hospital — Xi'an
- Xi 'an International Medical Center Hospital — Xi'an
- The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital) — Xi'an
- … and 7 more centers
Identifiers
NCT: NCT06128252 · K202308-01