NCT06389500尚未招募2 期
Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab and Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer: a Single-arm, Exploratory Clinical Study
Harbin Medical University0 个研究点目标入组 30 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Surgery conversion rate
研究概览
简要总结
This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer.
详细描述
This study plans to recruit 30 patients with borderline resectable, locally advanced biliary tract cancer who have not received treatment， abserve and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib.
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
- •Age: 18 to 75 years old, male or female;
- •Biliary tract malignant tumors confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan ≥10mm, meeting RECIST 1.1 standards);
- •Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma;
- •Clinical stage: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma stage: IIIA-IV;
- •Expected survival > 3 months;
- •ECOG PS score: 0-1 points;
- •Liver function classification is Child-Pugh ≤7;
- •Never received prior systemic treatment for biliary tract tumors;
- •No peritoneal metastasis or other distant metastasis;
- •Normal function of major organs;
- •Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing potential and men (who have sexual active with women of childbearing potential) must agree to effective contraception uninterrupted for the duration of the treatment and for 6 months after the last therapeutic dose;
- •Patients voluntarily enrolled in the study by signing an informed consent form.
排除标准
- •Patients diagnosed with periampullary cancer;
- •Previous or concurrent other malignant tumours within 5 years, except cervical carcinoma in situ, cutaneous squamous cell carcinoma or basal cell carcinoma of the skin that has been basically controlled;
- •Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
- •Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function;
- •Suffering from active autoimmune diseases, history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Reduced thyroid function after thyroid hormone replacement therapy can be included;
- •Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
- •Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to: 1) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
- •Severe active infection requiring intravenous antibiotic treatment occurs during the screening period;
- •Those who are allergic to experimental drugs;
- •Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits;
- •Those who the researcher believes are not suitable to participate in this trial.
研究组 & 干预措施
HAIC+Immune-targeted therapy
Experimental
Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib
干预措施: Adebrelimab (Drug)
HAIC+Immune-targeted therapy
Experimental
Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib
干预措施: Lenvatinib (Drug)
HAIC+Immune-targeted therapy
Experimental
Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib
干预措施: Hepatic Arterial Infusion Chemotherapy (Procedure)
结局指标
主要结局
Surgery conversion rate
时间窗: up to 24 months
Proportion of patients who can undergo surgical resection among all enrolled patients
R0 resection rate
时间窗: up to 24 months
Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.
次要结局
- Recurrence-free survival(up to 24 months)
- AEs(up to 24 months)
- Major pathological response rate(up to 24 months)
- Objective response rate(up to 24 months)
- pathological complete response rate(up to 24 months)
- Overall survival(up to 24 months)
研究者
Yubao Zhang
MD
Harbin Medical University
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