RecruitingNot ApplicableNCT04865471

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

Sponsor

Azienda Ospedaliera di Padova

Enrollment

18 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

Liver Metastases

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria13

≥ 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 Criteria7

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