Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma (pCOLA)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status

Enrolling

Conditions

Klatskin Tumor

Perihilar Cholangiocarcinoma

Study type

Observational

Funder types

Other

Identifiers

NCT06986486

254-24

Details and patient eligibility

About

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).

Full description

Patients with unresectable pCCA who fit within inclusion criteria will be enrolled in the study. They will undergo staging laparoscopy with nodal sampling at the hepatic hilum. In case of negative staging (no peritoneal carcinomatosis, no positive hilar lymph nodes, negative peritoneal washing), they will receive downstaging with gemcitabine-cisplatin +/- durvalumab for 2 cycles, followed by SBRT, followed by at least 4 other cycles of gemcitabine-cisplatin +/- durvalumab. After downstaging, they will undergo disease restaging and, if at least disease stability is confirmed, they will undergo transplant screening and listing. Treatment with gemcitabine-cisplatin + durvalumab will continue until liver transplant, progression or unacceptable toxicity.

During listing, restaging will be performed every two months with CT scan and/or MRI, molecular markers and FDG-PET. The target interval between listing and transplant should be less than 90 days.

Enrollment

8 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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