RECRUITINGINTERVENTIONAL

Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥ 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 willing to sign a consent form and expected cooperation of the patients for the treatment and follow up Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

Liver transplantation

Auxiliary liver transplantation and staged hepatectomy

Locations (1)

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

Padova, Italy