Resection And Partial Liver Segmental Transplantation Wit... | NCT04865471

Studies
Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

NCT04865471

Sponsor

Azienda Ospedaliera di Padova

Status

Unknown status

Last Update Posted

Apr 23, 2024Actual

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Liver Metastases

Interventions

Liver transplantation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Oct 2025Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Apr 28, 2021

First Posted Date

Apr 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2024

Last Update Posted Date

Apr 23, 2024Actual

Name	Class
Istituto Oncologico Veneto IRCCS	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver transplantation	Experimental	Auxiliary liver transplantation and staged hepatectomy	Procedure: Liver transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver transplantation	Procedure	Auxiliary liver transplantation and staged hepatectomy	Liver transplantation

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Umberto Cillo, MD	Contact	049.8212211-1897	+39	cillo@unipd.it
Sara Lonardi, MD	Contact			sara.lonardi@iov.veneto.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova	Recruiting	Padova		35128	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics