Combining taurine with chemotherapy and immunotherapy for advanced gastric cancer treatment
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
This study is testing if adding taurine to chemotherapy and immunotherapy can help people with advanced gastric cancer feel better and improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tang-Du Hospital Academic / other |
| Drugs / interventions | serplulimab, chemotherapy |
| Locations | 6 sites (Xi'an, Shaanxi and 5 other locations) |
| Trial ID | NCT06128252 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed gastric or gastroesophageal junction adenocarcinoma at stage II/III and specific tumor characteristics.
Not a fit: Patients with HER-2 positive tumors or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with locally advanced gastric cancer.
How similar studies have performed: While the combination of taurine with chemotherapy and immunotherapy is a novel approach, similar studies have shown promise in enhancing treatment efficacy in cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Xi'an, Shaanxi and 5 other locations
- 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)
- Xi 'an International Medical Center Hospital — Xi'an, Shaanxi, China (Recruiting)
- The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital) — Xi'an, Shaanxi, China (Recruiting)
- Xi'an NO.3 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.