Clinical trial · Interventional
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma: a Prospective Exploratory Trial
NCT04993131CI-TRIAL-00092899TESLA IIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Klatskin Tumor | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
| Perihilar Cholangiocarcinoma | Bile Duct Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liver transplant
- description
- 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.
- interventionNames
- Procedure: Liver transplant
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From screening and until 36 months after inclusion
- description
- Patient record
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * 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 * Twelve months or more time span from the diagnosis of pCCA and date of being listed for liver transplantation Exclusion criteria * 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
References
Publications (0)
Data not yet available
No reference posted for this study.