Biliary Drainage Plus HAIC in Locally Advanced pCCA

NCT05024513 | Completed Phase 2

• 1 other identifier: DRAIC
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Perihilar Cholangiocarcinoma

Keywords

Perihilar Cholangiocarcinoma; Hepatic arterial infusion chemotherapy; Biliary Drainage; Best Supportive Care

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  1 year

Secondary Outcomes (1)

• Duration of jaundice remission

  1 year

Other Outcomes (1)

• Adverse effects

  6 months

Study Arms (2)

BD-HAIC (Biliary drainage & HAIC)

EXPERIMENTAL

The patients enrolled in this arm would receive external percutaneous biliary drainage plus 3Cir-OFF hepatic arterial infusion chemotherapy （HAIC）with oxaliplatin and 5-fluorouracil.

Drug: oxaliplatin and 5-fluorouracil; Procedure: External biliary drainage

BD-BSC (Biliary Drainage & Best supportive care)

ACTIVE COMPARATOR

The patients enrolled in this arm would receive biliary drainage, biliary stents,or biliary stents with Iodine-125 seed strands, plus best supportive care.

Procedure: Biliary Drainage; Other: Best Supportive Care

Interventions

Biliary Drainage PROCEDURE

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

BD-BSC (Biliary Drainage & Best supportive care)

Best Supportive Care OTHER

Nutrition support, symptomatic treatment, and other supportive treatments

BD-BSC (Biliary Drainage & Best supportive care)

External biliary drainage PROCEDURE

External biliary drainage

BD-HAIC (Biliary drainage & HAIC)

oxaliplatin and 5-fluorouracil DRUG

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.

BD-HAIC (Biliary drainage & HAIC)

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

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

Beijing, China

Location

Related Publications (9)

• 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.

  PMID: 28994423 BACKGROUND

• 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.

  PMID: 27095655 BACKGROUND

• 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.

  PMID: 30831002 BACKGROUND

• 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.

  PMID: 29502573 BACKGROUND

• 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.

  PMID: 20431764 BACKGROUND

• 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.

  PMID: 20375404 BACKGROUND

• 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.

  PMID: 25176325 BACKGROUND

• 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.

  PMID: 30885278 BACKGROUND

• 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.

  PMID: 27820684 BACKGROUND

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaodong Wang

  Department of Interventional Oncology, Peking University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: November 1, 2021
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)