Liver‑artery chemotherapy plus immunotherapy for advanced unresectable intrahepatic cholangiocarcinoma

HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial

This test tries whether giving gemcitabine+cisplatin directly into the liver artery (HAIC) combined with a PD‑1/PD‑L1 immunotherapy (durvalumab or pembrolizumab) helps people with advanced, initially unresectable intrahepatic cholangiocarcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eastern Hepatobiliary Surgery Hospital (Academic / other)
• Drugs / interventions: Durvalumab, Pembrolizumab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07364305 on ClinicalTrials.gov

What this trial studies

This is a prospective phase 2 interventional study of GC‑HAIC (gemcitabine+cisplatin delivered by hepatic arterial infusion) combined with PD‑1/PD‑L1 immunotherapy (durvalumab or pembrolizumab) in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma. Patients must have measurable disease by RECIST 1.1, ECOG 0–1, Child‑Pugh A or B, adequate organ function, and no prior systemic treatment for ICC. The protocol aims to measure tumor response, conversion-to-resection rates, progression‑free survival, overall survival, and safety outcomes. Treatment effect and adverse events will be followed prospectively at Shanghai Eastern Hepatobiliary Surgery Hospital.

Who should consider this trial

Good fit: Adults (≥18) with histologic or radiologic diagnosis of advanced unresectable intrahepatic cholangiocarcinoma, at least one measurable lesion, ECOG 0–1, Child‑Pugh A/B, adequate organ function, and no prior systemic therapy are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), poor liver function (Child‑Pugh >8), life expectancy under three months, other active malignancies, or prior systemic treatment for ICC are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, this approach could shrink liver tumors enough to allow surgical removal and improve disease control and survival.

How similar studies have performed: Some small series and early trials show HAIC and systemic chemotherapy can control liver disease and checkpoint inhibitors have activity in biliary cancers, but combining HAIC with PD‑1/PD‑L1 blockade for unresectable ICC remains largely experimental with limited phase 2 evidence.

Eligibility criteria

Inclusion Criteria:

1. Age: Age ≥ 18 years old.
2. Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.
3. Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).
4. Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.
5. Expected lifespan: Expected lifespan ≥ 3 months.
6. Liver function: Child Pugh classification A or B.
7. Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.
8. Not receiving relevant treatment: Not receiving systematic treatment for ICC.

Exclusion Criteria:

1. Previous treatment: Previously received systemic treatment for ICC.
2. Poor physical condition: ECOG physical condition score ≥ 2.
3. Poor liver function: Child Pugh grading\>8.
4. Short life expectancy: Life expectancy is less than 3 months.
5. Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors.
6. Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.
7. Drug allergy or intolerance: Allergic to the investigational drug or its excipients.
8. Other: Other situations that the researcher deems unsuitable to participate in this study

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Eastern Hepatobiliary Surgery Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions ICC; Advanced Cancer; HAIC; Immunotherapy