HAIC Rechallenge in Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety in Patients Resistant to Previous Systemic Chemotherapy

West China Hospital72 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Biliary Tract Cancer

Interventions

Hepatic Arterial Infusion Chemotherapy (HAIC) RechallengeDRUG

Hepatic arterial infusion chemotherapy is delivered via hepatic artery catheter for liver-targeted chemotherapy administration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria:Inclusion Criteria: 1. Pathologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma) or colorectal cancer with liver metastases. 2. 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. 3. Interval between the last cycle of prior systemic chemotherapy and initiation of HAIC rechallenge is at least 1 month. 4. At least one measurable target lesion in the liver per RECIST 1.1 criteria. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2. 6. Adequate major organ function to meet the requirements for HAIC treatment. 7. Voluntarily signed informed consent form. \- Exclusion Criteria:Exclusion Criteria: 1. Extensive extrahepatic metastases (except for isolated, locally manageable pulmonary or lymph node metastases). 2. Contraindications to HAIC, including severe coagulopathy, complete portal vein main trunk tumor thrombus, or Child-Pugh class C liver function. 3. Prior local therapies (such as ablation or radiotherapy) before HAIC rechallenge that would interfere with target lesion assessment. 4. Concomitant other uncontrolled malignancies. 5. Pregnant or breastfeeding women. \-

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

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.

Time frame: 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.

Progression-Free Survival (PFS)

Time from the start of HAIC rechallenge to disease progression (RECIST 1.1) or death from any cause, whichever occurs first.

Time frame: Up to 36 months from the start of HAIC rechallenge treatment.

Secondary Outcomes

Disease Control Rate (DCR)

Disease control rate defined as the percentage of patients with CR, PR or stable disease (SD) per RECIST 1.1, evaluated by contrast-enhanced CT/MRI.

Time frame: 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)

Time from the start of HAIC rechallenge to death from any cause. Patients alive at last follow-up will be censored.

Time frame: Up to 36 months from the start of HAIC rechallenge treatment.

Incidence of Adverse Events

The incidence and severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame: Throughout the treatment period and up to 30 days after the last HAIC cycle.

Data from ClinicalTrials.gov

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