NCT07326189Not yet recruiting
Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma
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
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 25 Dec 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07326189
What you commit to
- Study type: Interventional
- Planned participants: 33
- From 1 Apr 2026 to the primary completion date, 31 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Allergy to iodinated contrast media.
Other
- Evidence of distant metastasis (M1).
- Pregnancy or lactation.
- Postoperative pathology confirms non-cholangiocarcinoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.