NCT05820906招募中2 期
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response rate ( ORR) per RECIST 1.1
研究概览
简要总结
To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer
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
- •subjects with a histopathological or cytologically diagnosis of BTC
- •The participants must be required to sign an informed consent
- •At least one measurable lesion (RECIST 1.1)
- •No previous systematic treatment for BTC
- •Child-Pugh Score, Class A
- •ECOG performance status 0 or 1
- •Adequate organ function
- •Life expectancy of at least 3 months
排除标准
- •Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma
- •Known history of serious allergy to any monoclonal antibody
- •Known central nervous system metastases and/or leptomeningeal disease prior to treatment
- •Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
- •Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
- •Any active malignancy prior to the start of treatment
- •Active or history of autoimmune disease
- •Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
- •Pregnant or lactating women
研究组 & 干预措施
Cadonilimab+rego+Gem/Cis
Experimental
干预措施: Cadonilimab+Regorafenib+GC (Drug)
结局指标
主要结局
Overall response rate ( ORR) per RECIST 1.1
时间窗: Up to 1 year
Defined as proportion of patients who have a best response of CR or PR
次要结局
- Progress Free Survival (PFS)(Up to two years)
- Disease control rate (DCR) per RECIST 1.1(Up to 1 year)
- Overall survival (OS)(Up to two years)
- Adverse Events (AEs)(Up to two years)
研究者
HuiKai Li
Professor and Chief Surgeon
Tianjin Medical University Cancer Institute and Hospital
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCCAdvanced Hepatocellular CarcinomaNCT05773105Sun Yat-sen University36
尚未招募
2 期
To Evaluate the Efficacy and Safety of Cadonilimab With SOX as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.Gastric CancerNCT05948449Sichuan University37
招募中
1 期
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Biliary Systemic TumoursAdvanced Biliary Systemic Tumours That Has Failed at Least One Prior Systemic TherapyNCT05644392Tianjin Medical University Cancer Institute and Hospital30
进行中（未招募）
1 期
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Advanced Hepatocellular CarcinomaAdvanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic TherapyNCT05644379Tianjin Medical University Cancer Institute and Hospital30
招募中
3 期
Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal CancerColorectal CancerNCT06566755Caigang Liu30