NCT04556214 Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
| NCT ID | NCT04556214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Intrahepatic Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2020-06-01 |
| 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 2020-06-01 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: * Histologically verified diagnosis of Intrahepatic Cholangiocarcinoma (iCCA) * First time iCCA or liver only recurrence after previous liver resection for iCCA * Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction * No vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging * No signs of extrahepatic metastatic disease according to positron emission computed tomography (PET-CT) scan * Patient must be accepted for transplantation before progressive disease on chemotherapy. * Twelve months or more time span from the diagnosis of iCCA and date of being listed for liver transplantation * No signs of extrahepatic metastatic disease according to CT or magnetic resonance (MR) 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) 0 or 1 * Signed informed consent and expected cooperation of the patients for the treatment and follow up * Received at least 6 months of chemotherapy or locoregional therapy Exclusion Criteria: * Major vascular involvement of the tumor * 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
Magnus Smedman, MD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT04556214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intrahepatic Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04556214 currently recruiting?
Yes, NCT04556214 is actively recruiting participants. Contact the research team at torha@ous-hf.no for enrollment information.
Where is the NCT04556214 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT04556214 clinical trial?
NCT04556214 is sponsored by Oslo University Hospital. The principal investigator is Magnus Smedman, MD at Oslo University Hospital. The trial plans to enroll 15 participants.