Home › Trials › NCT07364305
Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Liver‑artery chemotherapy plus immunotherapy for advanced unresectable intrahepatic cholangiocarcinoma

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

Run by Eastern Hepatobiliary Surgery Hospital · NCT07364305 · Data updated 2026-11-12

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.

More Advanced Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment50 (estimated)
SponsorEastern Hepatobiliary Surgery Hospital
Academic / other
Drugs / interventionsDurvalumab, Pembrolizumab, chemotherapy
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJanuary 1, 2028
Study endsJanuary 1, 2028
Registry record updatedJanuary 23, 2026
Trial IDNCT07364305 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Shanghai Eastern Hepatobiliary Surgery Hospital
    Shanghai, Shanghai Municipality, China     Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Advanced Cancer 146Eastern Hepatobiliary Surgery Hospital 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.