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

Starting soon · Phase 2

Conditions studied: Liver Cancer

In brief

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 facts

Study ID

NCT07685535

Run by

Shanghai Zhongshan Hospital

People needed

29

Starts

2026-06-30

Expected to finish

2028-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Expected survival ≥12 weeks.
• No prior treatment with immune checkpoint inhibitors (including PD-1/PD-L1 antibodies and CTLA-4 inhibitors).
• Laboratory values within 7 days before enrollment meeting the following criteria:
• ANC ≥1.0×10⁹/L; platelets ≥50×10⁹/L; hemoglobin ≥90 g/L (without transfusion or G-CSF within 14 days before screening).
• Serum albumin ≥30 g/L; total bilirubin ≤1.5×ULN; ALT and AST ≤5×ULN; serum creatinine ≤1.5×ULN or CrCl >50 mL/min (Cockcroft-Gault formula).
• INR ≤2.3 or PT prolonged ≤6 seconds above normal range.
• Urine protein <2+ (if ≥2+, 24-hour quantification <1.0 g allowed).

You may not qualify if…

• 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.
• 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).
• Major vascular disease within 6 months before study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).
• Severe, non-healing, or dehisced wounds, active ulcers, or untreated fractures.
• Major surgery within 4 weeks before study treatment (excluding diagnostic) or anticipated need for major surgery during the study.
• History of intestinal obstruction or clinical signs/symptoms of GI obstruction within 6 months before study treatment.
• History of hepatic encephalopathy.
• Palliative radiotherapy for non-target lesions allowed only if completed ≥2 weeks before study treatment and AEs recovered to ≤CTCAE grade 1.
• Severe infection within 4 weeks before study treatment, including hospitalization for infection, bacteremia, or severe pneumonia; oral or IV therapeutic antibiotics within 2 weeks (prophylactic allowed).
• Congenital or acquired immunodeficiency (e.g., HIV infection).
• Palliative radiotherapy involving >5% of bone marrow area within 4 weeks for patients with bone metastases.
• Received live attenuated vaccine within 28 days before study treatment, or expected to receive such vaccine during toripalimab treatment or within 60 days after last dose.
• Received other investigational drugs within 28 days before study treatment.
• Other factors judged by the investigator that may affect study results or cause premature termination, such as alcoholism, drug abuse, other serious diseases (including psychiatric) requiring concomitant treatment, severe laboratory abnormalities, family or social factors affecting patient safety.

Full record on ClinicalTrials.gov

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