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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID

NCT06128252

Run by

Tang-Du Hospital

People needed

96

Starts

2024-09-01

Expected to finish

2027-06-30

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Xi-jing Hospital — Xi'an, Shaanxi, China (enrolling)
• Tang-Du Hospital — Xi'an, Shaanxi, China (enrolling)
• Shaanxi Provincial People's Hospital — Xi'an, Shaanxi, China (enrolling)
• Xi 'an International Medical Center Hospital — Xi'an, Shaanxi, China (enrolling)
• The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital) — Xi'an, Shaanxi, China (enrolling)
• Xi'an NO.3 hospital — Xi'an, Shaanxi, China (enrolling)
• The Third People's Hospital of Chengdu — Chengdu, Sichuan, China (enrolling)
• Cancer Hospital Affiliated to Xinjiang Medical University — Ürümqi, Xinjiang Uygur Autonomous Region, China (enrolling)
• The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Chongqing, China (enrolling)
• The First Affiliated Hospital of Army Medical University (Southwest Hospital) — Chongqing, China (enrolling)
• Army Specialty Medical Center of PLA (Daping Hospital) — Chongqing, China (enrolling)
• Fudan University Shanghai Cancer Center (FUSCC) — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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