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Perihilar CholangiocarcinomaPhase 2NCT05024513

Biliary Drainage Plus HAIC in Locally Advanced pCCA

A Phase 2 study testing oxaliplatin and 5-fluorouracil, Biliary Drainage and External biliary drainage in people with Perihilar Cholangiocarcinoma, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Biliary drainage and stent placement remains to be the main palliative treatment choice for advanced perihiliar cholangiocarcinoma (pCCA), and the life expectancy is only 4-6 months. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Perihilar Cholangiocarcinoma
What is being tested?
oxaliplatin and 5-fluorouracil, Biliary Drainage and External biliary drainage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteChina
Study dates
1 Nov 2021to 20 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Locally advanced perihilar cholangiocarcinoma proved by histology or cytology.
  • Locally advanced unresectable perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.
  • Age from 18 years old to 80 years old.
  • The performance of Eastern Cooperative Oncology Group (ECOG) <2
  • Child-Pugh A or Child-Pugh B (≤ grade 7).
  • Expectant survival time ≥ 3 months.
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  • Baseline blood count test and blood biochemical must meet following criteria:
  • Hemoglobin ≥ 90 g/L;
  • Absolute neutrophil count ≥ 1.5×10^9/L;
  • Blood platelet count ≥ 100×10^9/L;
  • Serum creatinine ≤ 1.5 times of ULN;
  • Albumin ≥ 30 g/L
  • Patients sign informed consent.

Who cannot join

  • Allergic to contrast agent.
  • Pregnant or lactational.
  • Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
  • Previous systematic chemotherapy or radiotherapy.
  • Patients with complications such as bile leakage and bleeding after PTCD
  • N2 lymphatic metastasis, extrahepatic metastasis, or coinstantaneous a lot of malignant hydrothorax or ascites.
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  • History of organ transplantation.
  • Coinstantaneous infection and need anti-infection therapy.
  • Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
  • Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
  • Without legal capacity.
  • Uncorrectable coagulation disorder.
  • Obvious abnormal in ECG or obvious clinical symptoms of heartdisease, like congestive heart failure (CHF), coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension.
  • Severe liver disease (like cirrhosis), renal disease, respiratory disease,unmanageable diabetes or other kinds of systematic disease.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute

    Beijing

Other trials in China

About this study

Official title: Prospective Multicentre Trial of Biliary Drainage Plus Hepatic Arterial Infusion Chemotherapy Versus Biliary Drainage Plus Best Supportive Care in Locally Advanced Perihilar Cholangiocarcinomas.

Biliary drainage and stent placement remains to be the main palliative treatment choice for advanced perihiliar cholangiocarcinoma (pCCA), and the life expectancy is only 4-6 months. Previous single center prospective phase 2 trial showed that hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin and 5-fluorouracil was an encouraging treatment choice for advanced pCCA due to its high tumor control, survival benefit, and low toxicity. Thus, the multicenter prospective controlled trial was designed to explore and confirm the survival benefit of biliary drainage plus hepatic arterial infusion chemotherapy with oxaliplatin and 5-fluorouracil compared with biliary drainage plus best support care treatment in locally advanced pCCA patients.

Read the detailed description

When a patient is not eligible for surgery, chemotherapy with gemcitabine and cisplatin can be considered for advanced biliary tract cancer. However, in the Advanced Biliary Tract Cancer, or ABC-02 trial in patients with pCCA, the efficacy of this regimen was not significantly higher than that of gemcitabine alone. Therefore, an optimal chemotherapeutic regimen has not been established for this subtype of cholangiocarcinoma. Currently, biliary drainage and stent placement remains to be the main palliative treatment choice, and the life expectancy is only 4-6 months. Previous single center prospective phase 2 trial showed that HAI with oxaliplatin and 5-fluorouracil was an encouraging treatment choice for advanced PCC due to its high tumor control, survival benefit, and low toxicity. So the multicenter prospective controlled trial was designed to explore and confirm the survival benefit of biliary drainage plus hepatic arterial infusion of oxaliplatin and 5-fluorouracil compared with biliary drainage plus best support care treatment in locally advanced pCCA patients.

Being tested
oxaliplatin and 5-fluorouracil, Biliary Drainage, Best Supportive Care, External biliary drainage
Keywords
Perihilar Cholangiocarcinoma, Hepatic arterial infusion chemotherapy, Biliary Drainage, Best Supportive Care
Medical subject headings
Klatskin Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oxaliplatin and 5-fluorouracilDrug

    Intra-arterial chemotherapy consisted of Oxaliplatin (40mg/m2 for 2 hours), 5-fluorouracil (800 mg/ m2 for22 hours) on days 1-3 every 4 weeks.

  • Biliary DrainageProcedure or surgery

    External biliary drainage, or biliary stent placement; Biliary stent placement plus Iodine-125 seed strands is allowed

  • Best Supportive CareOther

    Nutrition support, symptomatic treatment, and other supportive treatments

  • External biliary drainageProcedure or surgery

    External biliary drainage

Study groups in NCT05024513
Study groupRoleWhat they receive
BD-HAIC (Biliary drainage & HAIC)ExperimentalThe patients enrolled in this arm would receive external percutaneous biliary drainage plus 3Cir-OFF hepatic arterial infusion chemotherapy （HAIC）with oxaliplatin and 5-fluorouracil.
Receives: Drug: oxaliplatin and 5-fluorouracil; Procedure: External biliary drainage
BD-BSC (Biliary Drainage & Best supportive care)Active comparatorThe patients enrolled in this arm would receive biliary drainage, biliary stents,or biliary stents with Iodine-125 seed strands, plus best supportive care.
Receives: Procedure: Biliary Drainage; Other: Best Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival is measured from the date of first biliary drainage to death

    Measured: 1 year

Secondary outcomes (1)

  1. Duration of jaundice remission

    The time between remission of total bilirubin to less than 2 times of the upper limit of the normal value and time of rising again of bilirubin above more than 2 times of upper limit of the normal level.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start1 Nov 2021
  3. Primary completion20 Oct 2025
  4. Study completion20 Oct 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024513
Sponsor's protocol ID
DRAIC
Status last verified
Dec 2025
First submitted
23 Aug 2021
Last updated
18 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: signed informed consent with patients

Publications

  • Ilyas SI, Khan SA, Hallemeier CL, Kelley RK, Gores GJ. Cholangiocarcinoma - evolving concepts and therapeutic strategies. Nat Rev Clin Oncol. 2018 Feb;15(2):95-111. doi: 10.1038/nrclinonc.2017.157. Epub 2017 Oct 10.

    PubMed 28994423

  • Banales JM, Cardinale V, Carpino G, Marzioni M, Andersen JB, Invernizzi P, Lind GE, Folseraas T, Forbes SJ, Fouassier L, Geier A, Calvisi DF, Mertens JC, Trauner M, Benedetti A, Maroni L, Vaquero J, Macias RI, Raggi C, Perugorria MJ, Gaudio E, Boberg KM, Marin JJ, Alvaro D. Expert consensus document: Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol. 2016 May;13(5):261-80. doi: 10.1038/nrgastro.2016.51. Epub 2016 Apr 20.

    PubMed 27095655

  • Forner A, Vidili G, Rengo M, Bujanda L, Ponz-Sarvise M, Lamarca A. Clinical presentation, diagnosis and staging of cholangiocarcinoma. Liver Int. 2019 May;39 Suppl 1:98-107. doi: 10.1111/liv.14086. Epub 2019 Mar 25.

    PubMed 30831002

  • Nath MC, Torbenson MS, Erickson LA. Perihilar Cholangiocarcinoma. Mayo Clin Proc. 2018 Mar;93(3):397-398. doi: 10.1016/j.mayocp.2018.01.017. No abstract available.

    PubMed 29502573

  • Park J, Kim MH, Kim KP, Park DH, Moon SH, Song TJ, Eum J, Lee SS, Seo DW, Lee SK. Natural History and Prognostic Factors of Advanced Cholangiocarcinoma without Surgery, Chemotherapy, or Radiotherapy: A Large-Scale Observational Study. Gut Liver. 2009 Dec;3(4):298-305. doi: 10.5009/gnl.2009.3.4.298. Epub 2009 Dec 31.

    PubMed 20431764

  • Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

    PubMed 20375404

  • Boehm LM, Jayakrishnan TT, Miura JT, Zacharias AJ, Johnston FM, Turaga KK, Gamblin TC. Comparative effectiveness of hepatic artery based therapies for unresectable intrahepatic cholangiocarcinoma. J Surg Oncol. 2015 Feb;111(2):213-20. doi: 10.1002/jso.23781. Epub 2014 Sep 1.

    PubMed 25176325

  • Hu J, Zhu X, Wang X, Cao G, Wang X, Yang R. Evaluation of percutaneous unilateral trans-femoral implantation of side-hole port-catheter system with coil only fixed-catheter-tip for hepatic arterial infusion chemotherapy. Cancer Imaging. 2019 Mar 18;19(1):15. doi: 10.1186/s40644-019-0202-z.

    PubMed 30885278

  • Wang X, Hu J, Cao G, Zhu X, Cui Y, Ji X, Li X, Yang R, Chen H, Xu H, Liu P, Li J, Li J, Hao C, Xing B, Shen L. Phase II Study of Hepatic Arterial Infusion Chemotherapy with Oxaliplatin and 5-Fluorouracil for Advanced Perihilar Cholangiocarcinoma. Radiology. 2017 May;283(2):580-589. doi: 10.1148/radiol.2016160572. Epub 2016 Nov 7.

    PubMed 27820684

  • Dai Y, Wang S, Gao J, Wang Y, Yang X, Zhang S, Zhi X, Zheng K, Xu L, Cao G, Xing B, Wang K, Hao C, Zhu X, Zhang DY, Gao DK, Wang DX. Biliary drainage plus hepatic arterial infusion chemotherapy versus biliary drainage plus best supportive care for advanced perihilar cholangiocarcinoma in China: a prospective multicentre non-randomised controlled study. EClinicalMedicine. 2026 Jul 2;97:104040. doi: 10.1016/j.eclinm.2026.104040. eCollection 2026 Jul.

    PubMed 42433279

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxaliplatin and 5-fluorouracil, Biliary Drainage and External biliary drainage in people with Perihilar Cholangiocarcinoma, run by Peking University at 1 site in China.

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 13 inclusion and 14 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: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 1 year). 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 NCT05024513, which also lists 10 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 18 Dec 2025.

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