A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cadonilimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Cadonilimab in combination with gemcitabine/cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must sign the written informed consent form (ICF) voluntarily；
- •Age ≥18 years and ≤65 years；
- •Subjects with histopathological diagnosis of nasopharyngeal carcinoma；
- •Primarily metastatic (stage IVB as defined by AJCC staging system for NPC, eighth edition) or recurrent/metastatic NPC that is not amenable to local regional treatment or curative treatment and at least 6 months after radical treatment；
- •Has not received prior systemic treatment;
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
- •Subject must have a measurable target lesion based on RECIST v1.1;
排除标准
- •Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;
- •Prior therapy as follow:
- •Anti-PD-1, anti-PD-L1 or anti-CTLA-4; Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment（Except：inhalation or topical corticosteroids）.
- •Any active malignancy ≤ 2 years before randomization except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)；
- •Female patients who are at pregnancy or lactation.
研究组 & 干预措施
Bispecific Antibody + GP Group
Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 years；
Gemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cycles；
Cisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles.
干预措施: Cadonilimab (Drug)
Bispecific Antibody + GP Group
Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 years；
Gemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cycles；
Cisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles.
干预措施: Gemcitabine (Drug)
Bispecific Antibody + GP Group
Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 years；
Gemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cycles；
Cisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: Up to approximately 2 years
ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
Incidence and severity of adverse events(AEs)
时间窗: Up to approximately 2 years
Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with chemotherapy.
次要结局
- Disease control rate (DCR)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)
研究者
Kai Hu
professor
Guangxi Medical University