Hepatic Arterial Infusion Chemotherapy Rechallenge for Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety Analysis in Patients With Prior Resistance to Systemic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Plain Language Summary This study uses hepatic arterial infusion chemotherapy (HAIC) rechallenge for patients with biliary tract cancer or colorectal cancer liver metastases whose disease has progressed after previous systemic chemotherapy. We aimed to evaluate the treatment's effectiveness and safety. The findings may help patients, family members and healthcare providers understand the benefits and risks of HAIC rechallenge for this patient group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Pathologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma) or colorectal cancer with liver metastases.
- •Received at least 2 cycles of prior systemic chemotherapy, with best response of stable disease (SD) followed by progression, or direct progressive disease (PD), indicating resistance to prior systemic chemotherapy.
- •Interval between the last cycle of prior systemic chemotherapy and initiation of HAIC rechallenge is at least 1 month.
- •At least one measurable target lesion in the liver per RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-
- •Adequate major organ function to meet the requirements for HAIC treatment.
- •Voluntarily signed informed consent form.
排除标准
- •Exclusion Criteria:
- •Extensive extrahepatic metastases (except for isolated, locally manageable pulmonary or lymph node metastases).
- •Contraindications to HAIC, including severe coagulopathy, complete portal vein main trunk tumor thrombus, or Child-Pugh class C liver function.
- •Prior local therapies (such as ablation or radiotherapy) before HAIC rechallenge that would interfere with target lesion assessment.
- •Concomitant other uncontrolled malignancies.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
HAIC Rechallenge Cohort
Patients with pathologically confirmed biliary tract cancer or colorectal cancer liver metastases who developed disease progression after prior systemic chemotherapy and received hepatic arterial infusion chemotherapy (HAIC) rechallenge. This retrospective observational study evaluates the efficacy and safety of HAIC rechallenge in this patient population.
干预措施: Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 24 weeks from the start of HAIC rechallenge treatment; tumor imaging assessments at baseline and every 6-8 weeks thereafter until 24 weeks.
Objective response rate defined as the percentage of patients with complete response (CR) or partial response (PR) assessed according to RECIST version 1.1. Tumor assessments were performed by contrast-enhanced CT/MRI.
Progression-Free Survival (PFS)
时间窗: Up to 36 months from the start of HAIC rechallenge treatment.
Time from the start of HAIC rechallenge to disease progression (RECIST 1.1) or death from any cause, whichever occurs first.
次要结局
- Disease Control Rate (DCR)(Up to 24 weeks from the start of HAIC rechallenge treatment; tumor imaging assessments at baseline and every 6-8 weeks thereafter until 24 weeks.)
- Overall Survival (OS)(Up to 36 months from the start of HAIC rechallenge treatment.)
- Incidence of Adverse Events(Throughout the treatment period and up to 30 days after the last HAIC cycle.)
研究者
Dai Ruihong
Junior Attending Doctor
West China Hospital