Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments

NCT06862934 | Recruiting

• 1 other identifier: 253-24
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Keywords

liver transplantation; transarterial radioembolization; downstaging

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival vs unresectable patients

  OS at 3 years after liver transplant will be matched and compared with OS of patients with similar characteristics that were not offered LT, taken from an institutional historical series and from patients found not eligible to LT due to medical/non-oncological conditions

  3 years

Secondary Outcomes (5)

• 3-year recurrence-free survival vs unresectable patients

  3 years

• 90-day morbidity

  90 days and long-term

• Quality of life

  3 years

• 3-year OS vs resectable patients

  3 years

• 3-year DFS vs resectable patients

  3 years

Study Arms (3)

Transplant

Patients enrolled within the study who undergo downstaging and liver transplantation after with various combinations of chemotherapy +/- immunotherapy and TARE

Controls 1 (unresectable)

Historical controls with the same inclusion criteria as the iCOLA protocol, treated with systemic and locoregional therapies and prospectively recruited patients with tumor response who refused transplantation or were not found eligible to LT for medical/non-oncological conditions

Controls 2 (resectable)

Patients with resectable iCC who underwent curative-intent liver resection, matched to the transplanted patients using demographic characteristics, tumor burden and pre-surgical therapies

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable liver-limited intrahepatic cholangiocarcinoma with no non-oncological contraindications to liver transplantation

You may qualify if:

• 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

You may not qualify if:

• Hilar and distal cholangiocarcinoma
• Progression of disease under chemotherapy +/- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria
• Evidence of lymph-nodal metastases
• Evidence of extrahepatic disease
• Prior extrahepatic metastatic 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
• Any reason why, in the opinion of the investigator, the patient should not participate to the study

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori di Milano

Milan, Milan, 20133, Italy

RECRUITING

Related Publications (1)

• Maspero M, Sposito C, Bongini MA, Cascella T, Flores M, Maccauro M, Chiesa C, Niger M, Pietrantonio F, Leoncini G, Bellia V, Bhoori S, Mazzaferro V. Liver Transplantation for Intrahepatic Cholangiocarcinoma After Chemotherapy and Radioembolization: An Intention-To-Treat Study. Transpl Int. 2024 Oct 31;37:13641. doi: 10.3389/ti.2024.13641. eCollection 2024.

  PMID: 39544321 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and transplant specimens

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Vincenzo Mazzaferro, MD, PhD

CONTACT

0223902760; vincenzo.mazzaferro@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: March 6, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-01

Locations

IT (1)