Back to resultsBiliary Drainage Plus HAIC in Locally Advanced pCCA
Primary Purpose
Perihilar Cholangiocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
oxaliplatin and 5-fluorouracil
Biliary Drainage
Best Supportive Care
External biliary drainage
Sponsored by
About this trial
This is an interventional treatment trial for Perihilar Cholangiocarcinoma focused on measuring Perihilar Cholangiocarcinoma, Hepatic arterial infusion chemotherapy, Biliary Drainage, Best Supportive Care
Eligibility Criteria
Inclusion Criteria:
- 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 75 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BD-HAIC (Biliary drainage & HAIC)
BD-BSC (Biliary Drainage & Best supportive care)
Arm Description
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.
The patients enrolled in this arm would receive biliary drainage, biliary stents,or biliary stents with Iodine-125 seed strands, plus best supportive care.
Outcomes
Primary Outcome Measures
Overall survival
Overall survival is measured from the date of first biliary drainage to death
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05024513
Brief Title
Biliary Drainage Plus HAIC in Locally Advanced pCCA
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perihilar Cholangiocarcinoma
Keywords
Perihilar Cholangiocarcinoma, Hepatic arterial infusion chemotherapy, Biliary Drainage, Best Supportive Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
127 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BD-HAIC (Biliary drainage & HAIC)
Arm Type
Experimental
Arm Description
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.
Arm Title
BD-BSC (Biliary Drainage & Best supportive care)
Arm Type
Active Comparator
Arm Description
The patients enrolled in this arm would receive biliary drainage, biliary stents,or biliary stents with Iodine-125 seed strands, plus best supportive care.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin and 5-fluorouracil
Intervention Description
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
Procedure
Intervention Name(s)
Biliary Drainage
Intervention Description
External biliary drainage, or biliary stent placement; Biliary stent placement plus Iodine-125 seed strands is allowed
Intervention Type
Other
Intervention Name(s)
Best Supportive Care
Intervention Description
Nutrition support, symptomatic treatment, and other supportive treatments
Intervention Type
Procedure
Intervention Name(s)
External biliary drainage
Intervention Description
External biliary drainage
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is measured from the date of first biliary drainage to death
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Duration of jaundice remission
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Toxicities were graded according to the Common Terminology Criteria for Adverse Events, version 4.0
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 75 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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Wang
Phone
18611586227
Email
xiaodongw75@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Wang
Organizational Affiliation
Department of Interventional Oncology, Peking University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Wang
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
signed informed consent with patients
Citations:
PubMed Identifier
28994423
Citation
Rizvi S, 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.
Results Reference
background
PubMed Identifier
27095655
Citation
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.
Results Reference
background
PubMed Identifier
30831002
Citation
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.
Results Reference
background
PubMed Identifier
29502573
Citation
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.
Results Reference
background
PubMed Identifier
20431764
Citation
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.
Results Reference
background
PubMed Identifier
20375404
Citation
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.
Results Reference
background
PubMed Identifier
25176325
Citation
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.
Results Reference
background
PubMed Identifier
30885278
Citation
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.
Results Reference
background
PubMed Identifier
27820684
Citation
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.
Results Reference
background
Learn more about this trial
Biliary Drainage Plus HAIC in Locally Advanced pCCA
We'll reach out to this number within 24 hrs