NCT04993131 Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
| NCT ID | NCT04993131 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Perihilar Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2035-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2021-09-01 with a primary completion date of 2035-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04993131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perihilar Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04993131 currently recruiting?
Yes, NCT04993131 is actively recruiting participants. Contact the research team at shya@ous-hf.no for enrollment information.
Where is the NCT04993131 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT04993131 clinical trial?
NCT04993131 is sponsored by Oslo University Hospital. The trial plans to enroll 15 participants.