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

Conditions

• Liver Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• DEB-TACE — DEVICE
  Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, administered via transarterial chemoembolization into the hepatic artery to occlude tumor blood vessels and deliver localized chemotherapy. Performed on Day 1 of each 21-day cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment).
• Toripalimab — DRUG
  200 mg administered as an intravenous infusion on Day 1 of each 21-day cycle. Toripalimab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 interaction, restoring T-cell anti-tumor immune activity.
• Lenvatinib — DRUG
  Oral daily dosing: 8 mg/day for body weight \<60 kg; 12 mg/day for body weight ≥60 kg. Lenvatinib is a multi-target tyrosine kinase inhibitor that inhibits VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET, thereby reducing tumor angiogenesis and suppressing tumor cell proliferation.
• Gemcitabine — DRUG
  Total dose 1000 mg/m² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. A portion of the dose is used for DEB-TACE drug loading; the remainder is administered via HAIC. Gemcitabine is a pyrimidine nucleoside analog that inhibits DNA synthesis and induces tumor cell apoptosis.
• Oxaliplatin — DRUG
  85 mg/m² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. Oxaliplatin is a third-generation platinum-based chemotherapeutic agent that forms DNA crosslinks, blocking DNA replication and transcription, and inducing tumor cell apoptosis.

Study Details

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.

Key Dates

First listed

Jul 6, 2026

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

29 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: HAIC + DEB-TACE + Toripalimab + Lenvatinib
  Participants receive a combination regimen consisting of: HAIC (Hepatic Arterial Infusion Chemotherapy): Oxaliplatin 85 mg/m² and gemcitabine (total 1000 mg/m², with a portion used for DEB-TACE loading) administered via hepatic artery infusion on Day 1 of each 21-day cycle, for up to 6 cycles. DEB-TACE (Drug-Eluting Beads Transarterial Chemoembolization): Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, performed on Day 1 of each cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment). Toripalimab: 200 mg intravenous infusion on Day 1 of each 21-day cycle. Lenvatinib: Oral daily dosing (8 mg/day for body weight \<60 kg; 12 mg/day for body weight ≥60 kg), continued throughout the study. After completion of up to 6 cycles, patients without disease progression enter a maintenance phase receiving toripalimab plus lenvatinib until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to t

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From the start of treatment until disease progression, up to 24 months ]

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