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

Primary Purpose

Liver Metastases

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Liver transplantation

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring Colorectal Liver Metastases, Auxiliary Liver Transplant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di PadovaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver transplantation

Arm Description

Auxiliary liver transplantation and staged hepatectomy

Outcomes

Primary Outcome Measures

Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation

Secondary Outcome Measures

Intention to treat survival after liver transplantation

Progression free survival

Proportion of drop out

Mortality

Complication rate

Full Information

NCT ID

NCT04865471

First Posted

February 23, 2021

Last Updated

April 28, 2021

Sponsor

Azienda Ospedaliera di Padova

Collaborators

Istituto Oncologico Veneto IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT04865471

Brief Title

Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

Acronym

RAPID-Padova

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

October 2025 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera di Padova

Collaborators

Istituto Oncologico Veneto IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Metastases

Keywords

Colorectal Liver Metastases, Auxiliary Liver Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Liver transplantation

Arm Type

Experimental

Arm Description

Auxiliary liver transplantation and staged hepatectomy

Intervention Type

Procedure

Intervention Name(s)

Liver transplantation

Intervention Description

Auxiliary liver transplantation and staged hepatectomy

Primary Outcome Measure Information:

Title

Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation

Time Frame

within 4 weeks from liver transplantation

Secondary Outcome Measure Information:

Title

Intention to treat survival after liver transplantation

Time Frame

3 and 5 years

Title

Progression free survival

Time Frame

3 and 5 years

Title

Proportion of drop out

Time Frame

within liver transplant

Title

Mortality

Time Frame

90 days from second stage hepatectomy

Title

Complication rate

Time Frame

90 days after liver transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Umberto Cillo, MD

Phone

049.8212211-1897

Ext

+39

cillo@unipd.it

First Name & Middle Initial & Last Name or Official Title & Degree

Sara Lonardi, MD

sara.lonardi@iov.veneto.it

Facility Information:

Facility Name

U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova

City

Padova

ZIP/Postal Code

35128

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Umberto Cillo, MD

cillo@unipd.it

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

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