Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT06128252
- Lead Sponsor
- Tang-Du Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Taurine + Serplulimab + XELOX Taurine Taurine + Serplulimab + XELOX chemotherapy regimen Taurine + Serplulimab + XELOX Serplulimab Taurine + Serplulimab + XELOX chemotherapy regimen Taurine + Serplulimab + XELOX XELOX regimen Taurine + Serplulimab + XELOX chemotherapy regimen Placebo + Serplulimab + XELOX Serplulimab Taurine placebo + Serplulimab + XELOX chemotherapy regimen Placebo + Serplulimab + XELOX XELOX regimen Taurine placebo + Serplulimab + XELOX chemotherapy regimen Placebo + Serplulimab + XELOX Placebo Taurine placebo + Serplulimab + XELOX chemotherapy regimen
- Primary Outcome Measures
Name Time Method Pathological complete response 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.
- Secondary Outcome Measures
Name Time Method R0 resection rate Through study completion, Within 1 week after operation The surgical margin is microscopically-negative for residual tumor.
Major pathological response (MPR) Through study completion, Within 1 week after operation Residual tumor cells below 10% in the resected specimen.
Objective response rate (ORR) 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.
Disease-free survival (DFS) 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.
Event-free survival (EFS) 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.
Overall survival (OS) 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.
Quality of life 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.
Changes in CD8+ T cell infiltration in tumor tissue 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.
Changes in CD8+ T cell death and function 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.
Safety endpoints 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.
Trial Locations
- Locations (6)
Xi-jing Hospital
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
Xi 'an International Medical Center Hospital
🇨🇳Xi'an, Shaanxi, China
The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
🇨🇳Xi'an, Shaanxi, China
Xi'an NO.3 hospital
🇨🇳Xi'an, Shaanxi, China
Tang-Du Hospital
🇨🇳Xi'an, Shaanxi, China