Clinical trial NCT04865471: Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy
Official title: Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Metastases
Keywords: Colorectal Liver Metastases
Auxiliary Liver Transplant
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
Collaborators: name: Istituto Oncologico Veneto IRCCS
First posted: 2021-04-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
timeFrame: within 4 weeks from liver transplantation
Secondary outcomes:
measure: Intention to treat survival after liver transplantation
timeFrame: 3 and 5 years
measure: Progression free survival
timeFrame: 3 and 5 years
measure: Proportion of drop out
timeFrame: within 100 days from listing
measure: Mortality
timeFrame: within 90 days from second stage hepatectomy
measure: Complication rate
timeFrame: within 90 days after liver transplant
Other outcomes:
Locations:
city: Padova
country: Italy
facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Study officials:
References: