Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma

NCT04993131 | Recruiting

• 1 other identifier: 270331
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.

Conditions

Perihilar Cholangiocarcinoma; Klatskin Tumor; Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Patient record

  From screening and until 36 months after inclusion

Secondary Outcomes (7)

• Overall survival from time of relapse

  From time of relapse and until 36 months after inclusion

• Disease free survival

  After liver transplantation and up 10 years after liver transplantation

• Time to start of new treatment/change in strategy

  Immediately after liver transplatation to start of new treatment

• Quality of life (EORTC QLQ-C30), time to decrease in physical function and global health score

  Up to 10 years after liver transplantation

• Complication according to Clavien-Dindo grad 3-5

  Up to 90 days after liver transplantation

Study Arms (1)

Liver transplant

EXPERIMENTAL

The patients will be transplanted according to standard procedures by the institutional protocol. Median time of surgery is 7 hours and 20 minutes. Each surgical procedure will be performed by specialists at the Rikshospitalet liver transplantation team, which consists of seven specialists at the unit. The transplantation procedure is initiated by an exploratory laparotomy with clinical assessment and frozen section of the lymphnodes in the hepatoduodenal ligament and along the common hepatic artery/coeliac axis. Complete clearance of the lymphatic tissue around the hepatoduodenal ligament. Frozen section is obtained from the distal end of the common bile duct. Evidence of disease dissemination to these regional lymph nodes will be an absolute contraindication to transplantation.

Procedure: Liver transplant

Interventions

Liver transplant PROCEDURE

Liver transplant.

Liver transplant

Eligibility Criteria

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

You may qualify if:

• Radiologically strong suspicion of pCCA
• Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein
• Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery
• First time pCCA
• Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction
• No extrahepatic disease, or lymph node involvement detected on imaging
• No signs of extrahepatic metastatic disease according to PET-CT scan
• No signs of extrahepatic metastatic disease according to CT or MR (chest/abdomen/pelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit
• At least 18 years of age
• Good performance status, Eastern Cooperative Oncology Group (ECOG) score: 0 or 1
• Satisfactory blood tests Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>50, Bilirubin\<3 x upper normal level, ASAT, ALAT\<5 x upper normal level, Creatinine \<1.5 x upper normal level. Albumin above lower normal level, Normal IgG4 levels
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations
• Received chemotherapy for at least 6 months with at least 10% response according ti RECIST criteria and with no progression of disease at time of Lt
• At least 10 months from diagnosis
• Patient must be accepted for transplantation before progressive disease

You may not qualify if:

• Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor
• Tumor involving main portal vein
• Tumor involving inferior vena cava
• Perforation of the visceral peritoneum
• Weight loss \>15% the last 6 months
• Patient BMI \> 30
• Other malignancies, except curatively treated more than 5 years ago without relapse
• Known history of human immunodeficiency virus (HIV) infection
• Prior history of solid organ or bone marrow transplantation
• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Known hypersensitivity to rapamycin
• Prior extrahepatic metastatic disease
• Women who are pregnant or breast feeding
• Any reason why, in the opinion of the investigator, the patient should not participate

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo university hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor; Bile Duct Neoplasms

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Central Study Contacts

Sheraz Yaqub, MD PhD

CONTACT

+4723073296; shya@ous-hf.no

Pål-Dag Line, MD PhD

CONTACT

+4723070509; pline@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor, MD PhD FEBS

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 6, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): May 31, 2035
• Study Completion (Estimated): May 31, 2045
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

NO (1)