Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma (TRANSPHIL)
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ClinicalTrials.gov Identifier: NCT02232932 |
Recruitment Status :
Active, not recruiting
First Posted : September 5, 2014
Last Update Posted : November 3, 2021
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A prospective, open-label, randomised, multicentre, comparative study in two parallel groups comparing an interventional group with liver transplantation preceded by neoadjuvant radio-chemotherapy and a control group receiving conventional liver and bile duct resection.
The primary endpoint will be overall survival at 5 years in the intent-to-treat population. The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the intent-to-treat population.
The number of subjects necessary is 54 patients (27 x 2): this population will enable the demonstration of a significant difference is 5-year survival rates between the transplanted group and the resected group with a power of 80% and a first-species risk of 5%, under the hypothesis that these survival rates are 70% in the transplanted group and 30% in the resected group.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholangiocarcinoma | Procedure: CAPECITABINE-Radiotherapy -Liver Transplantation Procedure: RESECTION | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Prospective Multicentric Study: Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Respectable Hilar Cholangiocarcinoma |
Study Start Date : | March 2014 |
Estimated Primary Completion Date : | February 2024 |
Estimated Study Completion Date : | September 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: CAPECITABINE-Radiotherapy -Liver Transplantation
Neoadjuvant Radio-Chemotherapy (RC) and Liver Transplantation (LT)
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Procedure: CAPECITABINE-Radiotherapy -Liver Transplantation
CAPECITABINE (800 mg/m2 twice a day during 5 weeks) + External Radiotherapy (50 grays during 5 weeks) then Liver transplantation
Other Name: Neoadjuvant Radio-Chemotherapy and Liver Transplantation |
Active Comparator: RESECTION
Liver resection
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Procedure: RESECTION
Intent-to-treat R0 liver resection
Other Name: Liver Resection |
- Overall survival [ Time Frame: At 5 years ]To demonstrate the superiority, in terms of 5-year survival, of liver transplantation (TH) preceded by neoadjuvant chemoradiotherapy on the radical resection of Klatskin tumors considered resectable
- Recurrence free survival [ Time Frame: At 3 years ]3-year recurrence-free survival assessed by CT and markers

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Ages Eligible for Study: | 18 Years to 68 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients (male or female) aged from 18 to 68 year-old, French
- Hilar cholangiocarcinoma histologically proved and/or highly suspected on hilar stenosis with mass syndrome from 0.1 cm to 3 cm
- Hilar cholangiocarcinoma type 2, type 3A, type 3B, type 4
- Patients considered as resectable (R0 resection) by liver resection including segment 1 and biliary confluence with or without vascular resection
- Patient potentially transplantable
- Patient affiliated to French Health Insurance
- Patient who had sign an informed consent
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Women of childbearing potential without an effective contraception method
- Radiotherapy contraindication
- Positive dosage of ImmunoglobulinsG4 (IgG4)
- dihydro-pyrimidine-dehydrogenase (DPD) total deficit
- Personal history of cancer in the last 5 five years (exclusion basocellular cellular carcinoma)
- Personal history of fluoropyrimidine hypersensibility
- Personal history of capecitabine hypersensibility
- Personal history of dihydro-pyrimidine-dehydrogenase deficit
- Polynuclear neutrophil < 1500 / ml
- Platelet rate < 100 000 / ml
- Severe leucopenia < 2000 / ml
- Severe liver failure (Factor V < 50%)
- Severe renal failure (Creatin clearance < 30 ml/min)
- Treatment by Sorivudine or its analogue as Brivudine
- Non controled diabetes mellitus and/or others severe co-morbidities (renal failure, severe and instable coronaropathy, severe risk factor of stroke, body mass index superior to 35)
- Proved histological cirrhosis
- Sclerosing cholangitis
- Intra and/or extra-hepatic metastases
- Hypereosinophilia and/or wirsung dilatation and/or mass of the pancreas head
- Hilar mass superior to 3 cm
- Duodenal invasion
- Patient under guardianship

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232932
France | |
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire | |
Villejuif, France, 94 |
Principal Investigator: | Eric VIBERT, MD | AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire, Villejuif, France |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT02232932 |
Other Study ID Numbers: |
P120106 |
First Posted: | September 5, 2014 Key Record Dates |
Last Update Posted: | November 3, 2021 |
Last Verified: | October 2021 |
Hilar cholangiocarcinoma Liver transplantation Radiochemotherapy |
Cholangiocarcinoma Klatskin Tumor Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Capecitabine Liver Extracts Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematinics |