NCT04978012招募中2 期
A Phase II Single-site the Study of the Efficacy and Safety of Fluzoparib and Camrelizumab in Treating Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma That Progressed After First-line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign an informed consent;
- •Age older than 18 years old and younger than 75 years old;
- •Patients with histologically confirmed recurrent/metastatic nasopharyngeal carcinoma, that progressed after at least first-line chemotherapy, according to RECIST 1.1 criteria;
- •No previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors;
- •At least one lesion that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria;
- •Anticipated overall survival more than 3 months;
- •Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-2;
- •Normal organ function;
- •HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
- •Male and no pregnant female, able to adapt birth control methods during treatment.
排除标准
- •Hypersensitivity to Fluzoparib or Camrelizumab;
- •Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
- •Necrotic disease, high-risk of massive bleeding;
- •Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
- •Severe, uncontrolled heart disease, such as more than NYHA II heart failure, unstable angina pectoris, myocardial infarction within 1 year prior to signing inform consent, severe arrhythmia that requires urgent intervention;
- •Previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors;
- •Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
- •Still suffered from adverse effect (more than CTCAE grade 1), that results from previous treatment;
- •Severe, uncontrolled infections within 28 days prior to signing inform consent;
- •Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
- •HIV positive;
- •Diagnosed as active pulmonary tuberculosis within one year before signing inform consent; or diagnosed as active pulmonary tuberculosis more than one year, but did not receive standardized anti-tuberculosis treatment;
- •Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
- •History of drug abuse, drug taking, alcohol abuse;
- •Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
- •Women of child-bearing potential who are pregnant or breastfeeding.
研究组 & 干预措施
Combination of Fluzoparib and Camrelizumab
Experimental
Fluzoparib,150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w
干预措施: Fluzoparib and Camrelizumab (Drug)
结局指标
主要结局
Overall response rate
时间窗: Within 2 year post-treatment
Overall response rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
次要结局
- Overall response rate by different PD-L1 TPS subgroups(Within 2 year post-treatment)
- Overall response rate by different homologous recombination repair status (HRR)(Within 2 year post-treatment)
- Duration of response(Within 2 year post-treatment)
- Progression-free survival rate at 6 month post-treatment(6 month post-treatment)
- Disease control rate(Within 2 year post-treatment)
- Overall survival rate at 6 month post-treatment(6 month post-treatment)
- Progression-free survival rate at 12 month post-treatment(12 month post-treatment)
- Overall survival rate at 12 month post-treatment(12 month post-treatment)
- Median progression-free survival(Within 2 year post-treatment)
- Median overall survival(Within 2 year post-treatment)
- Adverse effect(Within 2 year post-treatment)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell CancerEsophageal CancerNCT04654403The First Affiliated Hospital of Zhengzhou University337
Unknown
2 期
Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)Triple Negative Breast CancerNCT04676997Shandong Cancer Hospital and Institute20
招募中
2 期
Neoadjuvant Camrelizumab Plus Chemotherapy in Triple Negative Breast CancerTriple Negative Breast Cancer (TNBC)NCT05088057Aiping Shi30
尚未招募
2 期
Camrelizumab Combined With Apatinib Mesylate and Standard Chemotherapy (Pemetrixed + Carboplatin) in Patients With Tyrosine Kinase Inhibitor Failure in ALK-positive Advanced NSCLCLung NeoplasmsNCT04425135The First Affiliated Hospital of Xiamen University59
招募中
2 期
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene MutationHer-2 Negative Breast CancerHRR Gene MutationNCT05761470Ying Lin66