Status:
RECRUITING
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
Lead Sponsor:
Tang-Du Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 achievi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06128252
Start Date
September 1 2024
End Date
June 30 2026
Last Update
January 7 2025
Active Locations (6)
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1
Xi-jing Hospital
Xi'an, Shaanxi, China, 710032
2
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038
3
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
4
Xi 'an International Medical Center Hospital
Xi'an, Shaanxi, China, 710100