Feasibility and efficacy of adjuvant gemcitabine chemotherapy after liver transplantation for proximal bile duct cancer

Phase 2

Recruiting

Conditions: MedDRA - 9373BILEDUCTCANCERSTAGEIMedDRA - 10059374: Bile duct cancer stage II
C24.0
C24.8
Extrahepatic bile duct
Overlapping lesion of biliary tract

Registration Number: DRKS00000805

Lead Sponsor: Charité Campus Virchow-Klinikum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Listing for liver transplantation:
•diagnosis of hilar cholangiocarcinoma
•tumor not curatively resectable
•obligatory staging laparotomy with diagnostic lymphadenectomy and histologic confirmation of negative lymph nodes
•negative pregnancy test
•informed consent

Randomization for adjuvant chemotherapy:
•liver transplantation within three months after listing for liver transplantation
•histologically proven proximal bile duct cancer
•curative resection of the tumor (R0)
•CT scan of the chest not older than 8 weeks before randomization showing no detectable distant metastases
•possibility to start adjuvant chemotherapy between 4 and 10 weeks after liver transplantation
•sufficient bone marrow function (WBC > 3.5/nl, platelets > 80/nl, hemoglobin > 8 g/dl)
•sufficient renal function (creatinin clearance = 30 ml/min)
•sufficient liver function (bilirubin < 3 mg/dl)

Exclusion Criteria

Listing for liver transplantation:
•locally very advanced, irresectable tumor infiltrating adjacent other organs, the main trunk of the hepatic artery
•a visible tumor mass on CT or MRI scan larger than 3 cm in diameter
•CA 19-9 levels > 1000 U/ml
•tumors suspicious for gallbladder cancer
•known lymph node or distant metastasis
•patients undergoing multi-organ transplantation or have undergone previous solid organ or bone marrow transplantation
•previous or intended photodynamic therapy, radiation, chemotherapy, brachytherapy
•previous tumor biopsy (except via ERC)
•previous completed or attempted surgery for hilar cholangiocarcinoma
•patients with known hypersensibility for gemcitabine
•pregnancy or breastfeeding
•general contraindications for liver transplantation
•HIV infection

Randomization for adjuvant chemotherapy:
• patients with biliary sepsis, intrahepatic abscesses or other complications (e.g. severe liver dysfunction) contraindicating adjuvant chemotherapy
•contraindications against study medication (including auxiliary substances)
•pregnancy or breastfeeding
•therapy with mTOR-inhibitors (sirolimus, everolimus)
•any clinically significant medical or surgical condition, that in the investigator`s opinion would preclude adjuvant chemotherapy
•participitation in other clinical trials

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients completing the complete 6 cycles of chemotherapy, measured 6 months after start of chemotherapy.

Secondary Outcome Measures

Name	Time	Method
• recurrence free survival at 12 months<br>• overall survival at 3 and 5 years<br>• complication rate (protocol defined high grade toxicities grade 3/4 CTC)<br>• number of patients, which could not be randomized (due to perioperative complications, no detectable bile duct cancer in the explanted liver or other reasons)<br>