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

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ClinicalTrials.gov Identifier: NCT04865471
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
Istituto Oncologico Veneto IRCCS
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Metastases Procedure: Liver transplantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Liver transplantation
Auxiliary liver transplantation and staged hepatectomy
 Procedure: Liver transplantation
Auxiliary liver transplantation and staged hepatectomy


Outcome Measures
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Primary Outcome Measures :
  1. Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation [ Time Frame: within 4 weeks from liver transplantation ]
    Rate of second stage hepatectomy performed within 4 weeks from transplatation


Secondary Outcome Measures :
  1. Intention to treat survival after liver transplantation [ Time Frame: 3 and 5 years ]
    Time from transplantation to either death or censoring

  2. Progression free survival [ Time Frame: 3 and 5 years ]
    Time from enrolement to either progression or censoring

  3. Proportion of drop out [ Time Frame: within 100 days from listing ]
    Rate of drop out from listing

  4. Mortality [ Time Frame: within 90 days from second stage hepatectomy ]
    Rate of death within 90 days after second stage hepatectomy

  5. Complication rate [ Time Frame: within 90 days after liver transplant ]
    Complications according to Dindo Clavien Classification


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865471


Contacts
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Contact: Umberto Cillo, MD 049.8212211-1897 ext +39 cillo@unipd.it
Contact: Sara Lonardi, MD sara.lonardi@iov.veneto.it

Locations
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Italy
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: Umberto Cillo, MD       cillo@unipd.it   
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Istituto Oncologico Veneto IRCCS
More Information
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Responsible Party: Prof. Umberto Cillo, Prof, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT04865471    
Other Study ID Numbers: AOP1838
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Umberto Cillo, Azienda Ospedaliera di Padova:
Colorectal Liver Metastases
Auxiliary Liver Transplant
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases