Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma

NCT07326189 | Not Yet Recruiting

• 1 other identifier: SYSKY-2025-989-02
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cholangiocarcinoma Non-resectable

Keywords

Perihilar cholangiocarcinoma; Hepatic artery embolization; Vascular invasion; Surgical conversion; Radical resection

Outcome Measures

Primary Outcomes (1)

• 1-Year Overall Survival

  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 Outcomes (5)

• Surgical Conversion Rate

  At the time of surgery

• R0 Rate

  At the time of surgery

• 1-Year and 3-Year Recurrence-Free Survival Rate

  1 year and 3 years post-surgery

• 3-Year Overall Survival

  3 years post-surgery

• Incidence of Major Complications (Clavien-Dindo ≥ Grade III)

  90 days post-surgery

Study Arms (1)

Preoperative Right Hepatic Artery Embolization + Surgery

EXPERIMENTAL

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

Interventions

Preoperative Right Hepatic Artery Embolization PROCEDURE

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.

Preoperative Right Hepatic Artery Embolization + Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Related Publications (6)

• Mizuno T, Ebata T, Yokoyama Y, Igami T, Yamaguchi J, Onoe S, Watanabe N, Kamei Y, Nagino M. Combined Vascular Resection for Locally Advanced Perihilar Cholangiocarcinoma. Ann Surg. 2022 Feb 1;275(2):382-390. doi: 10.1097/SLA.0000000000004322.

  PMID: 32976284 BACKGROUND

• Li B, Li Z, Qiu Z, Qin Y, Gao Q, Ao J, Ma W, Jiang X. Surgical treatment of hilar cholangiocarcinoma: retrospective analysis. BJS Open. 2023 May 5;7(3):zrad024. doi: 10.1093/bjsopen/zrad024.

  PMID: 37194459 BACKGROUND

• Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.

  PMID: 37075781 BACKGROUND

• Kang MJ, Jang JY, Chang J, Shin YC, Lee D, Kim HB, Kim SW. Actual Long-Term Survival Outcome of 403 Consecutive Patients with Hilar Cholangiocarcinoma. World J Surg. 2016 Oct;40(10):2451-9. doi: 10.1007/s00268-016-3551-9.

  PMID: 27206402 BACKGROUND

• Burris HA 3rd, Okusaka T, Vogel A, Lee MA, Takahashi H, Breder V, Blanc JF, Li J, Bachini M, Zotkiewicz M, Abraham J, Patel N, Wang J, Ali M, Rokutanda N, Cohen G, Oh DY. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1): patient-reported outcomes from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2024 May;25(5):626-635. doi: 10.1016/S1470-2045(24)00082-2.

  PMID: 38697156 BACKGROUND

• Benson AB 3rd, D'Angelica MI, Abrams T, Ahmed A, Akce M, Anaya DA, Anders R, Are C, Aye L, Bachini M, Baker M, Binder D, Brown DB, Burgoyne A, Castellanos J, Cloyd J, Cullinan D, Franses J, Glazer ES, Harris W, Iyer R, Jennings L, Kelley RK, Khan S, Levine M, Melstrom L, Palta M, Raman S, Ronnekleiv-Kelly S, Sahai V, Stein S, Stephans K, Thanikachalam K, Turk A, Vauthey JN, Venook AP, Yano M, Yopp A, Zhao K, Schonfeld R, Hochstetler C. Biliary Tract Cancers, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2025 Sep;23(9):403-418. doi: 10.6004/jnccn.2025.0042.

  PMID: 40930144 BACKGROUND

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Xiangde Shi, Doctor

CONTACT

+86-13826064911; sxdsdgsdg@126.com

Chao Liu, Doctor

CONTACT

020-34070840

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: January 16, 2026

Record last verified: 2025-12