Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

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Source: NCT06986486

Recruiting

pCOLA: Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma

Cholangiocarcinoma

Phase not listed

Fondazione IRCCS Istituto Nazionale Tumori di Milano

Italy

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Last Updated: May 23, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).

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Study Type

Diagnostic

Radiation

Positron

Radiopharmaceutical

F-18 Fludeoxyglucose

Target

Glucose metabolism

Trial Started

June 1, 2025

Last Updated by Sponsor

May 23, 2025

Estimated Completion

January 1, 2030

Eligibility

Inclusion Criteria

* Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:

* Transcatheter biopsy or brush cytology

* CA-19.9 > 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography

* Biliary ploidy by FISH with a malignant appearing stricture on cholangiography

* Age between 18 years and 70 years

* Absence of intra- and extrahepatic metastases

* Absence of lymph-nodal metastases at any site

* Biliary stenting of all liver districts

* No contraindications to liver transplantation

* No concomitant malignancies or history of other malignancies in the previous 5 years

* Written informed consent

Exclusion Criteria

* Intrahepatic cholangiocarcinoma

* Uncontrolled infection

* Concomitant malignancies or history of other malignancies in the previous 5 years

Design Details

AllocationN/A

Intervention ModelN/A

MaskingN/A

Number to Enroll8

Arms & Interventions

Arms

Interventions

Type: N/A

Description: Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation

Interventions:

Outcome Measures

Primary Outcome Measures

3-year overall survival3 years

To evaluate overall survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol

Secondary Outcome Measures

3-year recurrence-free survival3 years

To evaluate recurrence-free survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol

Safety and feasibility3 years

To evaluate the safety and feasibility of neoadjuvant SBRT and chemotherapy in patients with unresectable hilar cholangiocarcinoma candidate to liver transplantation, in particular we will describe in detail the therapeutic path of all patients with unresectable pCCA that enter within the downstaging pathway and are evaluated for LT, how many are able to be transplanted within this protocol, and what are the reasons for dropout from the protocol

Quality of life3 years

To evaluate the impact of this treatment strategy and of LT on quality of life in patients with unresectable pCCA. Quality of life will be assessed with validated questionnaires. Questionnaires will be performed at baseline and at 6 months intervals; they will be matched and compared with that of eligible patients recruited within the same study period and receiving non-transplant treatments

Trial Sites

This study has 1 trial site

Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Michigan, IT

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