NCT06862934Recruiting
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)
Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is single-arm, observational, academic, investigator-driven study investigating the efficacy of liver transplantation after successful and sustained downstaging/tumor control of liver-limited unresectable intrahepatic cholangiocarcinoma. The downstaging protocol includes chemotherapy +/- immunotherapy and transarterial radioembolization (TARE) with Yttrium-90 in various combinations.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 14 (estimated)
- First submitted
- 27 Jan 2025
- Start date
- 20 Mar 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06862934
What you commit to
- Study type: Observational
- Planned participants: 14
- From 20 Mar 2025 to the primary completion date, 31 Dec 2027
- 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 extrahepatic metastatic disease
Other illness
- Progression of disease under chemotherapy +/- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria
- Evidence of extrahepatic disease
- Concomitant malignancies or history of other malignancies in the previous 5 years
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Other
- Hilar and distal cholangiocarcinoma
- Evidence of lymph-nodal metastases
- Any reason why, in the opinion of the investigator, the patient should not participate to the study
Who the study is looking for
- Histological diagnosis of iCCA (biopsy-proven tumor)
- Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection)
- Unresectability assessment due to tumor location (leading to insufficient live remnant with/out implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan).
- Age between 18 and 70 years
- No macrovascular tumor invasion (NB: portal vein and/or hepatic vein occlusion from the external tumor compression and classified as "encasement" could be considered after expert radiology review)
- No extrahepatic spread
- Disease stability for at least 6 months
- CA 19-9 \< 200 u/ml at transplant listing in absence of jaundice
- No medical and surgical contraindications to liver transplantation
- Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1
- No concomitant malignancies or history of other malignancies in the previous 5 years
- Written informed consent
Age in the registry: 18 years to 70 years · 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 |
|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale Tumori di Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.