Liver transplantation for patients with inoperable bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of liver transplantation in patients with non-resectable perihilar cholangiocarcinoma, focusing on survival rates, side effects, and quality of life. It will analyze blood and tissue samples to identify potential recurrence of the disease post-transplantation. Additionally, the impact of chemotherapy on liver tissues will be examined to enhance treatment protocols. The study aims to provide insights into the viability of liver transplantation as a treatment option for this challenging cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Oslo university hospital
  Oslo, Norway Recruiting

Study contacts

• Study coordinator: Sheraz Yaqub, MD PhD
• Email: shya@ous-hf.no
• Phone: +4723073296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.