NCT06986486

Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma

Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8 (estimated)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Perihilar Cholangiocarcinoma
• Klatskin Tumor

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2025-05-23
• Last updated: 2025-05-23

Locations

1 site across 1 country: Italy