Trial reportTransplantation2016
Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial.
Trial report in Transplantation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 189 papers, 9 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
189 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment, and follow-up of patients with hepatocellular carcinoma.ESMO open · 2026Guideline
- Guideline
- Asian Pacific Association for the Study of the Liver clinical practice guidelines on liver transplantation.Hepatology international · 2024Guideline
- Evidence-Based Management of Hepatocellular Carcinoma: Systematic Review and Meta-analysis of Randomized Controlled Trials (2002-2020).Gastroenterology · 2021Pooled it
- Pooled it
- Pooled it
- Pooled it
- Maintenance immunosuppression for adults undergoing liver transplantation: a network meta-analysis.The Cochrane database of systematic reviews · 2017Pooled it
- Use of Everolimus in Liver Transplantation: Recommendations From a Working Group.Transplantation · 2017Guideline
- Trial
- PD-L1Technology in cancer research & treatmentTrial
- The Evolving Role of Immunotherapy in the Treatment with Curative Purpose of Early, Intermediate and Advanced Stage Hepatocellular Carcinoma.Current oncology (Toronto, Ont.) · 2026Review
- Pulmonary Metastasectomy After Liver Transplantation: Indications, Timing, and Surgical Decision-Making Across Primary Tumor Histologies.Diagnostics (Basel, Switzerland) · 2026Review
- Liver Transplantation for Unresectable Colorectal Liver Metastases: Evidence, Patient Selection, and Clinical Implementation.Cancers · 2026Review
- Engineering CAR T Cells for Hepatocellular Carcinoma Recurrence after Liver Transplantation.bioRxiv : the preprint server for biology · 2026Article
- Multifaceted role of histopathology in liver transplantation for hepatocellular carcinoma: A narrative review towards precision prognosis.World journal of transplantation · 2026Article
- Standardized Management Pathway to Prevent Acute Rejection After Liver Transplantation Following ICI Therapy for Downstaging HCC.Health care science · 2026Article
- Redefining Liver Transplantation Indications for Hepatic Malignancies in the Era of Precision Transplant Oncology: An Up-to-Date Narrative Review.Journal of clinical medicine · 2026Review
- A Retrospective Multicenter Study Identifies a Similar Overall Survival of Patients After Liver Transplantation With Incidental Cholangiocarcinoma Compared to Hepatocellular Carcinoma.Clinical transplantation · 2026Observational
- Post-transplant hepatocellular carcinoma: balancing immunosuppression and immune checkpoint inhibitors.Clinical and molecular hepatology · 2026Review
129 more citing papers are in PubMed but not listed here.
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Authors and funding
67 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).
methodsIn a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor-free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor-free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overall survival (OS) was a secondary endpoint.
resultsRecurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (P = 0.28; hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62; 1.15). In a planned analysis of RFS rates at yearly intervals, group B showed better outcomes 3 years after transplantation (HR, 0.7; 95% CI, 0.48-1.00). Similarly, OS (P = 0.21; HR, 0.81; 95% CI, 0.58-1.13) was not statistically better in group B at study end, but yearly analyses showed improvement out to 5 years (HR, 0.7; 95% CI, 0.49-1.00). Interestingly, subgroup (Milan Criteria-based) analyses revealed that low-risk, rather than high-risk, patients benefited most from sirolimus; furthermore, younger recipients (age ≤60) also benefited, as well sirolimus monotherapy patients. Serious adverse event numbers were alike in groups A (860) and B (874).
conclusionsSirolimus in LTx recipients with HCC does not improve long-term RFS beyond 5 years. However, a RFS and OS benefit is evident in the first 3 to 5 years, especially in low-risk patients. This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with HCC.
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