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NCT Number: NCT07830147

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

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.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 0-2.
  • Adequate major organ function to meet the requirements for HAIC treatment.
  • Voluntarily signed informed consent form.

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Exclusion criteria

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.

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Treatment and study plan

Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge

Drug

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

Primary outcomes

  1. Objective Response Rate (ORR)

    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.

    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.

  2. Progression-Free Survival (PFS)

    Time frame: 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.

Secondary outcomes

  1. Disease Control Rate (DCR)

    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.

    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.

  2. Overall Survival (OS)

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

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

  3. Incidence of Adverse Events

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

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

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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