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Biliary Drainage Plus HAIC in Locally Advanced pCCA

NCT ID: NCT05024513

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Perihilar Cholangiocarcinoma

Keywords

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Perihilar Cholangiocarcinoma Hepatic arterial infusion chemotherapy Biliary Drainage Best Supportive Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BD-HAIC (Biliary drainage & HAIC)

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.

Group Type EXPERIMENTAL

oxaliplatin and 5-fluorouracil

Intervention Type 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.

External biliary drainage

Intervention Type PROCEDURE

External biliary drainage

BD-BSC (Biliary Drainage & Best supportive care)

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

Group Type ACTIVE_COMPARATOR

Biliary Drainage

Intervention Type PROCEDURE

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

Best Supportive Care

Intervention Type OTHER

Nutrition support, symptomatic treatment, and other supportive treatments

Interventions

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oxaliplatin and 5-fluorouracil

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.

Intervention Type DRUG

Biliary Drainage

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

Intervention Type PROCEDURE

Best Supportive Care

Nutrition support, symptomatic treatment, and other supportive treatments

Intervention Type OTHER

External biliary drainage

External biliary drainage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Locally advanced perihilar cholangiocarcinoma proved by histology or cytology.
2. Locally advanced unresectable perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.
3. Age from 18 years old to 80 years old.
4. The performance of Eastern Cooperative Oncology Group (ECOG) \<2
5. Child-Pugh A or Child-Pugh B (≤ grade 7).
6. Expectant survival time ≥ 3 months.
7. Baseline blood count test and blood biochemical must meet following criteria:

1. Hemoglobin ≥ 90 g/L;
2. Absolute neutrophil count ≥ 1.5×10\^9/L;
3. Blood platelet count ≥ 100×10\^9/L;
4. Serum creatinine ≤ 1.5 times of ULN;
5. Albumin ≥ 30 g/L
8. Patients sign informed consent.

Exclusion Criteria

1. Allergic to contrast agent.
2. Pregnant or lactational.
3. Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
4. Previous systematic chemotherapy or radiotherapy.
5. Patients with complications such as bile leakage and bleeding after PTCD
6. N2 lymphatic metastasis, extrahepatic metastasis, or coinstantaneous a lot of malignant hydrothorax or ascites.
7. History of organ transplantation.
8. Coinstantaneous infection and need anti-infection therapy.
9. Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
10. Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
11. Without legal capacity.
12. Uncorrectable coagulation disorder.
13. 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.
14. Severe liver disease (like cirrhosis), renal disease, respiratory disease,unmanageable diabetes or other kinds of systematic disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Xiaodong Wang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaodong Wang

Role: PRINCIPAL_INVESTIGATOR

Department of Interventional Oncology, Peking University Cancer Hospital

Locations

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

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 28994423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27095655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30831002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29502573 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20431764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20375404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25176325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30885278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27820684 (View on PubMed)

Other Identifiers

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DRAIC

Identifier Type: -

Identifier Source: org_study_id