A prospective, single-arm,mutil-center study to assess the efficacy and safety of Surufatinib combined with Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma.
This study adopt Simon's two-stage Optimal designs method based on the primary endpoint of objective response rates. 4 patients were planned for the first stage. If one or more responses were observed, an additional 8 patients were to be accrued for a total of 12 patients. If 4 or more of the 12 patients achieved an objective response, then this study was designated worthy of additional investigation.Considering a 10% abscission rate, a total of 14 patients were included. Surufatinib(250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Surufatinib(250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met .
Affiliated Cancer Hospital of Sun Yat-sen University
Guangdong, China
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Progression Free Survival (PFS)
To assess the efficacy of Surufatinib and Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma. patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: up to 12 months
Overall survival time
OS was calculated from the date of pharmacy to death from any cause.
Time frame: up to 36 months
Assess the anti-tumor activity:DCR
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Duration of relief (DOR)
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
Time frame: through study completion, an average of 1 year
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