NCT04556214Recruiting
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Source: ClinicalTrials.gov · Last updated 11 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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..
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 30 Jun 2020
- Start date
- 1 Jun 2020
- Primary completion date
- 31 May 2035
- Lead sponsor
- Oslo University Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04556214
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Jun 2020 to the primary completion date, 31 May 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of solid organ or bone marrow transplantation
- Prior extrahepatic metastatic disease
Other illness
- Perforation of the visceral peritoneum
- Other malignancies, except curatively treated more than 5 years ago without relapse
- Known history of human immunodeficiency virus (HIV) infection
- 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
Other
- Major vascular involvement of the tumor
- Weight loss \>15% the last 6 months
- Patient BMI \> 30
- Women who are pregnant or breast feeding
- Any reason why, in the opinion of the investigator, the patient should not participate
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.