Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
概览
简要总结
At present, the first-line treatment for patients with advanced unresectable intrahepatic cholangiocarcinoma is mainly systemic treatment, but the improvement in efficacy is limited and is not enough to meet the current clinical treatment needs. Hepatic artery infusion chemotherapy (HAIC) has the advantages of increasing local drug concentration and reducing toxic side effects compared to systemic intravenous chemotherapy. In order to enable patients with advanced intrahepatic cholangiocarcinoma to obtain better treatment effects, this study plans to explore HAIC combined with durvalumab and lenvatinib as the first-line treatment for patients with locally advanced or metastatic ICC, in order to provide a better treatment choice for their comprehensive treatment.
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
- •Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.
- •Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis
- •Disease recurrence \> 6 months after radical surgery; if adjuvant therapy is given after surgery, patients \> 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy) are eligible for inclusion.
- •WHO/ECOG PS of 0 or 1
- •There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria
排除标准
- •Patients who have received systemic treatment in the past.
- •Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
- •Patients with severe and uncorrectable coagulation dysfunction.
- •Patients with active hepatitis or severe infection who cannot be treated simultaneously.
- •Patients with cachexia or multiple organ failure.
研究组 & 干预措施
HAIC-quad Arm
干预措施: Lenvatinib (Drug)
HAIC-quad Arm
干预措施: Durvalumab (Drug)
HAIC-quad Arm
干预措施: hepatic arterial infusion chemotherapy (HAIC) (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 26 months
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
次要结局
- Overall Survival (OS)(Up to approximately 36 months)
- Progression-free Survival (PFS)(Up to approximately 26 months)
- Number of Participants Who Experience One or More Adverse Events (AE)(Up to approximately 36 months)
研究者
Wen Tianfu
Director of Liver Surgery Department, West China Hospital, Sichuan University
West China Hospital