Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liver transplantation
- description
- Auxiliary liver transplantation and staged hepatectomy
- interventionNames
- Procedure: Liver transplantation
Primary outcomes (1)
- measure
- Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
- timeFrame
- within 4 weeks from liver transplantation
- description
- Rate of second stage hepatectomy performed within 4 weeks from transplatation
Secondary outcomes (5)
- measure
- Intention to treat survival after liver transplantation
- timeFrame
- 3 and 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available