NCT06128252Recruiting
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
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
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 2 Nov 2023
- Start date
- 1 Sept 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06128252
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 1 Sept 2024 to the primary completion date, 30 Jun 2027
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;
Other illness
- 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.
Other
- Patients with positive HER-2;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third People's Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of Army Medical University (Southwest Hospital) Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Army Specialty Medical Center of PLA (Daping Hospital) Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Affiliated Drum Tower Hospital, Medical School of Nanjing University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Fudan University - Shanghai Cancer Center (FUSCC) Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Cancer Hospital Affiliated to Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Xi-jing Hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Shaanxi provincial people's hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Xi 'an No.3 Hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Xi'an International Medical Center Hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital) Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Tang-Du Hospital Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.