NCT07830147Completed
HAIC Rechallenge in Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety in Patients Resistant to Previous Systemic Chemotherapy
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 72 (actual)
- First submitted
- 9 Sept 2026
- Start date
- Jan 2015
- Primary completion date
- Dec 2025
- Lead sponsor
- West China Hospital
- NCT number
- NCT07830147
What you commit to
- Study type: Observational
- Participants enrolled: 72
- From Jan 2015 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior local therapies (such as ablation or radiotherapy) before HAIC rechallenge that would interfere with target lesion assessment.
- Concomitant other uncontrolled malignancies.
Other
- 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.
- Pregnant or breastfeeding women.
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Who the study is looking for
- 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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Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.