Combining taurine with chemotherapy and immunotherapy for advanced gastric cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of oral taurine supplementation alongside a PD-1 inhibitor (serplulimab) and chemotherapy in patients with locally advanced gastric cancer. The study aims to enhance systemic CD8+ T cell responses and improve patient outcomes compared to serplulimab and chemotherapy alone. Participants will receive either the taurine treatment or a placebo in conjunction with the standard chemotherapy regimen. The trial focuses on patients with specific tumor characteristics and performance status to ensure appropriate candidate selection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Affiliated Drum Tower Hospital, Medical School of Nanjing University
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting
• Xi-jing Hospital
  Xi'an, Shaanxi, China Recruiting
• Tang-Du Hospital
  Xi'an, Shaanxi, China Recruiting
• Shaanxi Provincial People's Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Xiaodi Zhao, MD, PhD — Xi-Jing Hospital
• Study coordinator: Xiaodi Zhao, MD, PhD
• Email: leedyzhao@fmmu.edu.cn
• Phone: 17702979587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.