Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy (NCT04865471) | Clinical Trial Compass
UnknownNot Applicable
Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy
Italy18 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
Timeframe: within 4 weeks from liver transplantation