Tislelizumab Plus Chemotherapy With Response-Adapted Radiotherapy for de Novo Metastatic Nasopharyngeal Carcinoma: A Prospective, Phase II Trial
NCT07248696 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-11-25
Summary
This study is aimed to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and response-adapted radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma
Conditions
- Nasopharyngeal Cancinoma (NPC)
Interventions
- RADIATION
-
response-adapted radiotherapy
Induction Treatment Regimen: • Tislelizumab+Gemcitabine+Cisplatin for 4-6 cycles . Response-Adapted Radiotherapy: * Patients achieving CR after induction therapy require no radiotherapy. * Patients achieving PR after induction therapy: Radiotherapy (55 Gy/20 fractions, 5 fractions per week, over 4 weeks) to the residual primary nasopharyngeal lesion and metastatic cervical lymph nodes. Radiotherapy for metastatic lesions concurrently or sequentially with locoregional radiotherapy. Immunotherapy Regimen: maintenance therapy with tislelizumab monotherapycontinues until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. The total treatment duration shall not exceed 2 years
Sponsors & Collaborators
-
Chongqing University Cancer Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-04
- Primary Completion
- 2029-06-30
- Completion
- 2029-06-30
Countries
- China
Study Locations
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