Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of L
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.
| Condition(s) | Gastric Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Tang-Du Hospital |
| Locations | Wuhan, Hubei, China; Nanjing, Jiangsu, China; Shenyang, Liaoning, China; Xi'an, Shaanxi, China; Xi'an, Shaanxi, China; Xi'an, Shaanxi, China (+9 more sites) |
| Start date | 2024-09-01 |
| NCT ID | NCT06128252 |
| Official listing | https://clinicaltrials.gov/study/NCT06128252 |