Purpose: This phase II clinical trial evaluates whether a combination of liver-directed local therapies (HAIC and DEB-TACE) with immunotherapy (toripalimab) and targeted therapy (lenvatinib) is safe and effective for patients with unresectable intrahepatic cholangiocarcinoma (a type of liver cancer that cannot be removed by surgery).
Participants: Adults aged 18-85 years with pathologically confirmed unresectable intrahepatic cholangiocarcinoma, no prior immune checkpoint inhibitor therapy, and adequate organ function.
Study details include:
Study Duration: Up to 24 months per participant
Treatment Duration: Up to 6 cycles (each cycle is 21 days) of combination therapy, followed by maintenance therapy with toripalimab and lenvatinib until disease progression or unacceptable toxicity
Visit Frequency: Every 3 weeks during the treatment phase; tumor imaging assessments every 6-8 weeks
Primary endpoints: Objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Safety will be assessed by monitoring adverse events graded according to NCI-CTCAE v5.0.
Toripalimab and lenvatinib are not available through an expanded access program.
Who can participate
Age range
18 Years – 85 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.
Inclusion criteria
. Voluntary participation and signed informed consent.
. Imaging-confirmed unresectable locally advanced intrahepatic cholangiocarcinoma with measurable lesions (longest diameter ≥10 mm) per RECIST 1.1.
. No distant organ metastases (excluding lymph node metastases).
. Child-Pugh liver function grade A or good B (≤7 points).
. ECOG performance status score 0-1 within 1 week before enrollment.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From the start of treatment until disease progression, up to 24 months
2
Progression-Free Survival (PFS)
Timeframe: From enrollment until disease progression or death, assessed up to 24 months
3
Overall Survival (OS)
Timeframe: From enrollment until death, assessed up to 24 months
. Concurrent or prior other malignancy within 5 years.
. Active autoimmune disease or history of autoimmune disease with potential relapse.
. Clinically symptomatic moderate-to-severe ascites requiring therapeutic paracentesis/drainage or Child-Pugh score \>2; uncontrolled or moderate-to-large pleural/pericardial effusion.
. History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months before study treatment.
. History of thrombosis or embolic events (e.g., cerebrovascular accident including TIA, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months before study treatment.
. Known inherited or acquired bleeding disorder or thrombotic tendency; currently or recently (within 10 days) receiving full-dose anticoagulants or thrombolytics for therapeutic purposes (prophylactic low-dose aspirin or LMWH allowed).