HAIC + DEB-TACE + Toripalimab + Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma

Summary

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.

Timeline

Start

2026-06-30

Primary completion

2028-06-30

Completion

2028-12-31

Drugs

Indications