Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy (RAPID-Padova)

Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma

RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.

Study Overview

• Status: Recruiting
• Conditions: Liver Metastases
• Intervention / Treatment: Procedure: Liver transplantation

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Umberto Cillo, MD; Phone Number: +39 049.8212211-1897; Email: cillo@unipd.it
• Study Contact Backup: Name: Sara Lonardi, MD; Email: sara.lonardi@iov.veneto.it

Study Locations

• Italy
  • Padova, Italy, 35128
    • Recruiting
    • U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
    • Contact: Umberto Cillo, MD; Email: cillo@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 and <70 years
• Performance status, ECOG 0-1
• Histologically proved adenocarcinoma in colon or rectum
• BRAF wild-type CRC on primary tumor or liver metastases
• High standard oncological surgical resection of the primary tumor
• Liver metastases not eligible for curative liver resection confirmed by the validation committee
• At least one line (3 months) of chemotherapy
• At least 6 months time span from CRC resection and date of being listed on the transplantation list.
• At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
• No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have <3 lung lesions all<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
• Satisfactory blood tests creatinine in normal level, PLT >60.000/mm3, GB>2500/mm3
• CEA stable or in decrease
• Signed informed consent and expected cooperation of the patients for the treatment and follow up

Exclusion Criteria:

• Weight loss >10% the last 6 months
• Patient BMI > 30
• Participation refusal
• General contraindication to LT
• Other malignancies in the previous 5 years
• Pregnancy or breast feeding
• Any reason why, in the opinion of the investigator, the patient should not participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liver transplantation; Auxiliary liver transplantation and staged hepatectomy	Procedure: Liver transplantation; Auxiliary liver transplantation and staged hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation	Rate of second stage hepatectomy performed within 4 weeks from transplatation	within 4 weeks from liver transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to treat survival after liver transplantation	Time from transplantation to either death or censoring	3 and 5 years
Progression free survival	Time from enrolement to either progression or censoring	3 and 5 years
Proportion of drop out	Rate of drop out from listing	within 100 days from listing
Mortality	Rate of death within 90 days after second stage hepatectomy	within 90 days from second stage hepatectomy
Complication rate	Complications according to Dindo Clavien Classification	within 90 days after liver transplant

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Padova
• Collaborators: Istituto Oncologico Veneto IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal Liver Metastases; Auxiliary Liver Transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: AOP1838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No