Cholangiocarcinoma Non-resectablePHAE-PHCCNCT07326189
Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma
A study testing Preoperative Right Hepatic Artery Embolization in people with Cholangiocarcinoma Non-resectable, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholangiocarcinoma Non-resectable
- What is being tested?
- Preoperative Right Hepatic Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Chao Liu, Doctor contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Cholangiocarcinoma Non-resectable
- Being tested
- Preoperative Right Hepatic Artery Embolization
- Keywords
- Perihilar cholangiocarcinoma, Hepatic artery embolization, Vascular invasion, Surgical conversion, Radical resection
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Right Hepatic Artery EmbolizationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Preoperative Right Hepatic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post-surgery
Secondary outcomes (5)
Surgical Conversion Rate
The proportion of enrolled patients who successfully undergo radical resection.
Measured: At the time of surgery
R0 Rate
The proportion of resected patients achieving microscopically negative cut margins at the axial and radial of bile duct tumor.
Measured: At the time of surgery
1-Year and 3-Year Recurrence-Free Survival Rate
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.
Measured: 1 year and 3 years post-surgery
3-Year Overall Survival
The proportion of patients alive at 3 years after the radical surgery date.
Measured: 3 years post-surgery
Incidence of Major Complications (Clavien-Dindo ≥ Grade III)
The proportion of patients experiencing post-procedural (embolization or surgery) complications graded as Clavien-Dindo III or higher within 90 days after surgery.
Measured: 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cholangiocarcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326189
- Sponsor's protocol ID
- SYSKY-2025-989-02
- Acronym
- PHAE-PHCC
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32976284Li 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.
PubMed 37194459Kelley 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.
PubMed 37075781Kang 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.
PubMed 27206402Burris 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.
PubMed 38697156Benson 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.
PubMed 40930144
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07326189
- Acronym / sponsor ID
- PHAE-PHCC / SYSKY-2025-989-02
- Conditions
- Cholangiocarcinoma Non-resectable
- Keywords
- Perihilar cholangiocarcinoma, Hepatic artery embolization, Vascular invasion, Surgical conversion, Radical resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Right Hepatic Artery Embolization + Surgery | Experimental | Procedure: Preoperative Right Hepatic Artery EmbolizationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Right Hepatic Artery EmbolizationParticipants 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 or surgery | Preoperative Right Hepatic Artery Embolization + Surgery |
Primary outcome
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.
5 secondary outcomes
Surgical Conversion Rate
Time frame: At the time of surgery
R0 Rate
Time frame: At the time of surgery
1-Year and 3-Year Recurrence-Free Survival Rate
Time frame: 1 year and 3 years post-surgery
3-Year Overall Survival
Time frame: 3 years post-surgery
Incidence of Major Complications (Clavien-Dindo ≥ Grade III)
Time frame: 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 32976284Mizuno 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.
- Background: PubMed 37194459Li 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.
- Background: PubMed 37075781Kelley 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.
- Background: PubMed 27206402Kang 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.
- Background: PubMed 38697156Burris 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.
- Background: PubMed 40930144Benson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Liu, Doctor contact
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Right Hepatic Artery Embolization in people with Cholangiocarcinoma Non-resectable, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangde Shi, Doctor (+86-13826064911, sxdsdgsdg@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Overall Survival (time frame: 1 year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07326189, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.