Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma (PHAE-PHCC)

January 14, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

A Prospective, Multicenter, Single-Arm Study on the Efficacy and Safety of Preoperative Right Hepatic Artery Embolization Combined With Surgical Resection for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma

This is a prospective, multicenter, single-arm study investigating the efficacy and safety of preoperative right hepatic artery embolization (PHAE) followed by surgical resection in patients with locally advanced Bismuth IIIb or IV perihilar cholangiocarcinoma (PHCC) involving the right hepatic artery. The standard treatment for such cases is often considered unresectable due to the high risk of hepatic ischemia after arterial resection without reconstruction. This study proposes a strategy: preoperative embolization of the tumor-involved right hepatic artery to stimulate the development of collateral arterial circulation (e.g., from the right inferior phrenic artery), enabling subsequent radical resection of the right hepatic artery without reconstruction. The primary objective is to evaluate the 1-year overall survival rate. Secondary objectives include surgical conversion rate, R0 resection rate, 1-year/3-year recurrence-free survival, 3-year overall survival rate and safety assessment. A total of 33 participants will be enrolled across multiple centers in China.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to validate a novel surgical strategy for locally advanced Bismuth IIIb or IV perihilar cholangiocarcinoma (PHCC) where the tumor involves the right hepatic artery (RHA), rendering the tumor conventionally unresectable due to the high risk of postoperative right hepatic lobe ischemia if the artery is resected without reconstruction. The intervention involves preoperative selective embolization of the tumor-involved RHA using coils. This procedure is intended to induce the development of collateral arterial supply to the right liver lobe from extrahepatic arteries (e.g., right inferior phrenic, adrenal, intercostal arteries) over a 2-4 week period. Following confirmation of collateral circulation via imaging, patients undergo radical left hepatectomy or left trisectionectomy with en-bloc resection of the involved RHA without arterial reconstruction. The study employs a single-arm design. The primary endpoint is the 1-year overall survival (OS) . The study is designed to detect an improvement to 75%, compared to a historical control rate of 54% observed with chemoimmunotherapy for unresectable disease. Secondary endpoints include surgical conversion rate, R0 resection rate, 1-year/3-year recurrence-free survival (RFS), 3-year OS, and safety profiles (incidence of liver abscess, bile leak, post-hepatectomy liver failure, and other Clavien-Dindo ≥ Grade III complications). The study involves multiple phases: screening/preparation (including biliary drainage and portal vein embolization if needed), the PHAE procedure, radical surgery (2-4 weeks post-PHAE), and a 3-year follow-up period. Statistical analysis will be performed on the intention-to-treat (FAS), per-protocol (PPS), and safety (SS) populations.

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chao Liu, Doctor
  • Phone Number: 020-34070840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent.
  • Age 18-80 years.
  • Clinical diagnosis of Bismuth IIIb or IV perihilar cholangiocarcinoma, deemed suitable for radical resection via left hepatectomy or left trisectionectomy.
  • Imaging (CTA/MRA) confirms tumor invasion of the right hepatic artery (RHA) that is assessed as "unable to be safely reconstructed after resection" (e.g., involvement of RHA branches or requiring vascular graft for reconstruction).
  • Portal vein on the side of the future liver remnant is not invaded or is reconstructable.
  • ECOG performance status 0-1.
  • Child-Pugh score ≤ 7 (Class A or B).
  • Adequate organ function (bone marrow, liver, kidney) as per protocol-defined laboratory values.
  • Expected survival ≥ 12 weeks.

Exclusion Criteria:

  • Evidence of distant metastasis (M1).
  • History of other malignancies within the past 5 years (except cured basal cell carcinoma or cervical carcinoma in situ).
  • Severe cardiac, pulmonary, renal, or cerebrovascular disease as specified in the protocol (e.g., recent myocardial infarction, severe COPD, chronic renal failure stage ≥ III).
  • Uncontrolled active infection or diabetes.
  • Pregnancy or lactation.
  • Allergy to iodinated contrast media.
  • Postoperative pathology confirms non-cholangiocarcinoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative Right Hepatic Artery Embolization + Surgery
Participants receive preoperative selective embolization of the tumor-involved right hepatic artery, followed 2-4 weeks later by radical left hepatectomy or left trisectionectomy with resection of the involved artery without reconstruction.
Procedure: Preoperative Right Hepatic Artery Embolization
Participants receive preoperative selective embolization of the tumor-involved right hepatic artery, followed 2-4 weeks later by radical left hepatectomy or left trisectionectomy with resection of the involved artery without reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Year Overall Survival
Time Frame: 1 year post-surgery
The proportion of patients alive at 1 year after the radical surgery date. Overall survival is defined as the time from surgery to death from any cause.
1 year post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Conversion Rate
Time Frame: At the time of surgery
The proportion of enrolled patients who successfully undergo radical resection.
At the time of surgery
R0 Rate
Time Frame: At the time of surgery
The proportion of resected patients achieving microscopically negative cut margins at the axial and radial of bile duct tumor.
At the time of surgery
1-Year and 3-Year Recurrence-Free Survival Rate
Time Frame: 1 year and 3 years post-surgery
The proportion of patients alive and free of tumor recurrence at 1 and 3 years after surgery. Recurrence-free survival is defined as the time from surgery to the first documented recurrence or death from any cause.
1 year and 3 years post-surgery
3-Year Overall Survival
Time Frame: 3 years post-surgery
The proportion of patients alive at 3 years after the radical surgery date.
3 years post-surgery
Incidence of Major Complications (Clavien-Dindo ≥ Grade III)
Time Frame: 90 days post-surgery
The proportion of patients experiencing post-procedural (embolization or surgery) complications graded as Clavien-Dindo III or higher within 90 days after surgery.
90 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2025-989-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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