Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

Liver Metastases Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865471
• Other study ID #: AOP1838
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Azienda Ospedaliera di Padova
• Contact: Umberto Cillo, MD
• Phone: 049.8212211-1897
• Email: cillo[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Liver transplantation
Auxiliary liver transplantation and staged hepatectomy

Locations

Country	Name	City	State
Italy	U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova	Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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