Clinical trial · Interventional
Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma
NCT05971628CI-TRIAL-00068453RAPID-HCCnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a national, non-randomized, multicentric trial evaluating the feasibility and the tolerance of the RAPID procedure in patients with HCC with preserved liver function requiring a liver 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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAPID procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Liver transplantation with the RAPID procedure
- description
- Liver transplantation for hepatocellular carcinoma according to the RAPID protocol. This protocol is an auxiliary liver transplantation of a partial graft with total hepatectomy in two stages (2 successive operations).
- interventionNames
- Procedure: RAPID procedure
- type
- NO_INTERVENTION
- label
- Comparator group with standard liver transplantation (whole graft)
- description
- Orthotopic liver transplantation with whole organ from deceased donor for hepatocellular carcinoma. Data will be provided by Biomedicine Agency, following pairing rules.
Primary outcomes (2)
- measure
- Proportion of patient with successful RAPID procedure
- timeFrame
- 4 months after the second RAPID step
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion criteria (RAPID receiver) * 18 years ≤ age ≤ 68 years * Indication of LT for HCC validated in multidisciplinary meeting * AFP score ≤ 2 (15) * Body mass index \< 30 kg/m2 * MELD score ≤ 15, without access to prioritization * PET CT-choline and PET CT-FDG without sign of extra-hepatic localizaton * Patient having been informed and able to give written consent to participate in the RAPID-HCC study * Validation of the patient's inclusion in the RAPID-HCC protocol by the scientific committee Exclusion criteria * History of, liver transplant, surgical or radiological portocaval anastomosis * History of major abdominal surgery (including hepatectomy) * History of abdominal radiotherapy (extrahepatic) * History of acute/chronic pancreatitis * Expected combined transplant * HCC located 1 cm away from the transection line required by the first stage hepatectomy * Portal or arterial thrombosis * patient with a pre-graft hepatic venous pressure gradient ≥ 20mmHg * Ascites (clinical or radiological) less than 5 years ago * Hepatitis C viral load + * Acute or chronic hepatitis B (not cured) * HIV + serology * Severe comorbidities, in particular severe cardiovascular or respiratory or renal pathology (at the discretion of the medical-surgical team) * Patient on anticoagulant treatment * Patient who has received (or is due to receive) preoperative treatment with radioembolization on the right side, hepatectomy or radiotherapy near the hilum * Patient who received (or should receive) preoperative treatment with anti-tyrosine kinase (TKI) less than three months ago * Patients receiving or having received immunotherapy Donor selection criteria: * Brain-dead donor (no living donor) * 18 years ≤ age ≤ 65 years * Hepatic, vascular and biliary anatomy compatible with performing a split. Analysis entrusted to the team that will carry out the split, and based on the scanner of the donor (to be available on the Biomedicine Agency website) * Biological and hepatic assessment compatible with the realization of a split, in particular transaminases \< 4 times the normal * Graft not assigned to a protocol requiring machine infusion. * Serology: anti-HBc negative, anti-HCV negative
References
Publications (1)
- DERIVEDPeloso A, Pietrasz D, Daillier E, Cylly L, Scatton O, Goumard C, Mabrut JY, Mohkam K, Lesurtel M, Dokmak S, Jeddou H, Boudjema K, Allard MA, Adam R, Sa Cunha A, Azoulay D, Cherqui D, Vibert E, Golse N. Resection and partial liver transplantation from deceased donors with delayed total hepatectomy (RAPID procedure) for hepatocellular carcinoma: a national, multicenter, non-randomized, prospective trial. BMC Cancer. 2025 May 9;25(1):848. doi: 10.1186/s12885-025-14127-7. PMID 40346479