Status:
RECRUITING
Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy
Lead Sponsor:
Azienda Ospedaliera di Padova
Collaborating Sponsors:
Istituto Oncologico Veneto IRCCS
Conditions:
Liver Metastases
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04865471
Start Date
October 1 2020
End Date
October 1 2025
Last Update
April 23 2024
Active Locations (1)
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1
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Padua, Italy, 35128