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

RecruitingNAAges 18 Years - 75 YearsAllTang-Du Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-75 years old, no gender limitation; 2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III,T≥3, N ≥0, M=0; 3. Expected survival of ≥ 3 months; 4. The tumor specimens were PD-L1 positive (CPS ≥ 1); 5. There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7. 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; 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. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use; 6. 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.
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What it tests

  • Taurine
  • Serplulimab
  • XELOX regimen
  • Placebo
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Where

15 sites
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, China
The First Affiliated Hospital of China Medical University
Shenyang, China
Xi-jing Hospital
Xi'an, China
Tang-Du Hospital
Xi'an, China
Shaanxi Provincial People's Hospital
Xi'an, China
Xi 'an International Medical Center Hospital
Xi'an, China
The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Xi'an, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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