The aim of this study is to define the efficacy and safety of Fluzoparib and Camrelizumab in treating patients with recurrent/metastatic nasopharyngeal carcinoma that progressed after first-line chemotherapy.
Currently, the standard first-line treatment for recurrent/metastatic nasopharyngeal carcinoma is cisplatin-based chemotherapy. The recommended subsequent line therapy is single-agent chemotherapy or single-agent PD-1 antibody (nivolumab or pembrolizumab), according to NCCN guidelines (head and neck cancer, version 2021.3). However, the efficacy of nivolumab or pembrolizumab in subsequent line setting is limited, range from 20-30%. In order to improve the efficacy, we launch this study to evaluate whether combination treatment of PARP inhibitor (Fluzoparib) and PD-1 antibody (Camrelizumab) has the potential to increase efficacy in the subsequent line treatment, meanwhile has tolerable adverse effect.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.
Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China
RECRUITINGOverall response rate
Overall response rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Time frame: Within 2 year post-treatment
Disease control rate
Disease control rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Time frame: Within 2 year post-treatment
Duration of response
Duration of response, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Time frame: Within 2 year post-treatment
Progression-free survival rate at 6 month post-treatment
Progression-free survival rate at 6 month post-treatment
Time frame: 6 month post-treatment
Overall survival rate at 6 month post-treatment
Overall survival rate at 6 month post-treatment
Time frame: 6 month post-treatment
Progression-free survival rate at 12 month post-treatment
Progression-free survival rate at 12 month post-treatment
Time frame: 12 month post-treatment
Overall survival rate at 12 month post-treatment
Overall survival rate at 12 month post-treatment
Time frame: 12 month post-treatment
Median progression-free survival
Median progression-free survival
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Time frame: Within 2 year post-treatment
Median overall survival
Median overall survival
Time frame: Within 2 year post-treatment
Adverse effect
Adverse effect, according to CTCAE 4.0.03 criteria
Time frame: Within 2 year post-treatment
Overall response rate by different PD-L1 TPS subgroups
Overall response rate by different PD-L1 TPS subgroups (≥1% vs. \<1%; ≥20% vs. \<20%; ≥50% vs. \<50%))
Time frame: Within 2 year post-treatment
Overall response rate by different homologous recombination repair status (HRR)
Overall response rate by different homologous recombination repair status(germline BRCA mutation/wildtype, HRD positive/negative, germline HRR genes mutations status)
Time frame: Within 2 year post-treatment