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GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.
Sponsor: Sun Yat-sen University
Summary
In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy.
Official title: Toripalimab Plus Anlotinib Combined with GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk, Locally Advanced Nasopharyngeal Carcinoma:A Single-arm, Phase II Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2025-01-03
Completion Date
2027-06
Last Updated
2025-02-28
Healthy Volunteers
No
Conditions
Interventions
Toripalimab
Fixed dose: 240mg/ time, add 100ml normal saline, intravenous infusion for 30 minutes (not less than 20 minutes, not more than 60 minutes). The first course of induction chemotherapy (D1) is used on the first day of each cycle, and every 21 days is a course of treatment up to 18 courses or one year. After intravenous infusion of triplelizumab, GP regimen induction chemotherapy was administered at an interval of 30-60 minutes.
Anlotinib
Oral administration before breakfast, 10mg/ time/day, once a day (d1-14), repeated every 3 weeks, using three courses, one week before radiotherapy discontinuation. Use on the day the first course of induction chemotherapy begins (D1).
Gemcitabine
1000mg/m2, D1, D8, add 0.9% normal saline 500ml, intravenous infusion. Every 21 days is a treatment cycle. If the recovery of toxicity in the subject is not sufficient for the next course of chemotherapy, the start of the next course of chemotherapy may be appropriately delayed, but the delay cannot exceed 21 days. The treatment was continued for 3 courses.
Cisplatin
Induction Chemotherapy: 80mg/m2, D1, add 1000ml 0.9% normal saline, intravenous infusion for 3 hours. Concurrent Chemoradiotherapy100mg/m2, add 5% glucose 500ml, intravenous drip. Use on the first day of each cycle, every 21 days for a treatment cycle
radiation
IMRT, 33Fx
Locations (1)
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China