Liver transplantation for patients with inoperable bile duct cancer
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma: a Prospective Exploratory Trial
This study is testing if liver transplantation can help people with inoperable bile duct cancer live longer and have a better quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04993131 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with a strong suspicion of perihilar cholangiocarcinoma who are not eligible for surgical resection due to tumor location or liver dysfunction.
Not a fit: Patients with extrahepatic disease or those who have signs of metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with inoperable bile duct cancer.
How similar studies have performed: While liver transplantation for other types of liver cancer has shown success, this specific approach for perihilar cholangiocarcinoma is still being explored and is considered novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Oslo
- Oslo university hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Sheraz Yaqub, MD PhD
- Email: shya@ous-hf.no
- Phone: +4723073296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.