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.
Voluntary participation and signed informed consent.
Age 18 to 85 years.
Pathologically confirmed intrahepatic cholangiocarcinoma.
Imaging-confirmed unresectable locally advanced intrahepatic cholangiocarcinoma with measurable lesions (longest diameter ≥10 mm) per RECIST 1.1.
Received other local treatments (excluding surgery) within 1 month before study entry. Prior TAE/TAI not allowed. Prior TACE >3 times not allowed.
Prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, chemotherapy).
Concurrent or prior other malignancy within 5 years.
Active autoimmune disease or history of autoimmune disease with potential relapse.