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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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