Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma
NCT07762976 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148
Last updated 2026-08-13
Summary
This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.
Conditions
- Nasopharyngeal Carcinoma (NPC)
Interventions
- OTHER
-
Observation
Clinical follow-up and surveillance only.
- DRUG
-
Adjuvant therapy
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles
- DRUG
-
Adjuvant therapy
Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles)
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Xiayun He · Fudan University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-07-31
- Completion
- 2031-07-31
Countries
- China
Study Locations
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