First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC
Stopped: Study was terminated due to unacceptable treatment-related toxicity that raised safety concerns and outweighed the potential benefits.
China1 participantsStarted 2024-04-01
Plain-language summary
The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. NYHA Class 2 or above heart failure
. Unstable angina
. Myocardial infarction within the past year
. Clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention
. QTc \>450 ms (males); QTc \>470 ms (females)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether its safety or treatment data would be useful for my situation?
2The trial was measuring adverse events as its main outcome, which means it was still figuring out how safe this combination of radiotherapy and HAIC is — given that, how does the known safety profile of this approach compare to standard first-line treatments for cholangiocarcinoma?
3Since this study focused on unresectable locally advanced distal cholangiocarcinoma but my diagnosis involves intrahepatic cholangiocarcinoma, how closely does my specific tumor location match what this trial was actually studying, and does that matter for my treatment options?
4Because this was a Phase 2 trial that was terminated, would you recommend I look into other active trials combining radiation and chemotherapy for cholangiocarcinoma, or is standard systemic therapy a more evidence-backed path for me right now?
5Are there currently any open trials or established treatment protocols that build on this type of HAIC and radiotherapy combination approach that might be worth considering for my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.