PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY
NCT06354140 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2024-07-17
Summary
To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy
Conditions
Interventions
- DRUG
-
Tegafur
Tegafur (S-1) 80mg/100mg/120mg Q3W (discontinued at the third week) + tislelizumab 200 mg Q3W, treatment for 1 year. Tegafur: body surface area (BSA) \< 1.25m2, use 80mg; 1.25-1.5m2, use 100mg; \> 1.5m2, use 120mg. Treatment for 1 year
Sponsors & Collaborators
-
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-07
- Primary Completion
- 2027-05-30
- Completion
- 2028-05-30
Countries
- China
Study Locations
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