Evidence map›Paper›PMID 33420951›Full record

Trial reportHepatology international2021

Phase 2 trial comparing sorafenib, pravastatin, their combination or supportive care in HCC with Child-Pugh B cirrhosis.

Jean-Frédéric Blanc, Faiza Khemissa, Jean-Pierre Bronowicki, Carole Monterymard, Jean-Marc Perarnau, Vincent Bourgeois, Stéphane Obled, Meher Ben Abdelghani, Isabelle Mabile-Archambeaud, Roger Faroux and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01357486 (Phase II Randomized Trial Evaluating the Administration of Sorafenib or Pravastatin or Association Sorafenib-pravastatin or Best Supportive Care for the Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01357486 phase2completednot on this map

Phase II Randomized Trial Evaluating the Administration of Sorafenib or Pravastatin or Association Sorafenib-pravastatin or Best Supportive Care for the Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis

TypeinterventionalSponsorUniversity Hospital, BordeauxRan2011 to 2017Enrolled160ConditionsHepatocellular Carcinoma, CHILD BArmssorafenib, Pravastatin, Sorafenib + Pravastatin, patients receiving best supportive care
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Impact of Child Pugh B Stage for the Treatment of Advanced HCC.Journal of hepatocellular carcinoma · 2026
    Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. [Strategies of statins for the prevention and treatment of hepatocellular carcinoma].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Cardiac Syndromes in Liver Disease: A Clinical Conundrum.Journal of clinical and translational hepatology · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 15 institutions in 1 country.

Jean-Frédéric BlancHepatology, CHU Bordeaux, (HOPITAL SAINT-ANDRE-CHU), 1 Rue Jean Burguet, 33000, Bordeaux, France. jean-frederic.blanc@chu-bordeaux.fr.
Faiza KhemissaCH Saint Jean, Perpignan, France.
Jean-Pierre BronowickiCHU Nancy-Brabois, Vandoeuvre les Nancy, France.
Carole MonterymardFFCD, Dijon, France.
Jean-Marc PerarnauCHU Tours Hôpital Trousseau, Tours, France.
Vincent BourgeoisHôpital Duchenne, Boulogne-Sur-Mer, France.
Stéphane ObledCHU Carémeau, Nîmes, France.
Meher Ben AbdelghaniCentre Paul Strauss, Strasbourg, France.
Isabelle Mabile-ArchambeaudCHU Hôtel Dieu, Nantes, France.
Roger FarouxCHD Vendée, La Roche-Sur-Yon, France.
Jean-François SeitzCHU la TIMONE, Marseille, France.
Christophe LocherCentre Hospitalier de Meaux, Meaux, France.
Hélène SenellartICO Centre René Gauducheau, Saint-Herblain, France.
Anne-Laure VillingCentre Hospitalier Auxerre, Auxerre, France.
Franck AudemarCH de la Côte Basque, Bayonne, France.
Charlotte CostentinAP-HP Hôpital Henri Mondor, Créteil, France.
Gaël DeplanqueGroupe Hospitalier Saint Joseph, Paris, France.
Sylvain ManfrediFaculté de Médecine, INSERM U1231, Université de Bourgogne, Franche-Comté, Dijon, France.
Julien EdelineCentre Eugène Marquis, Rennes, France.ORCID http://orcid.org/0000-0002-8289-7741
PRODIGE 21 collaborators
Centre Hospitalier Régional et Universitaire de Nancy · FRInstitut Génétique Nantes Atlantique · FRCentre Eugène Marquis · FRHôpital de la Timone · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier de la Côte Basque · FRCentre Hospitalier de Perpignan · FRCentre Hospitalier Universitaire de Nîmes · FRCentre Hospitalier Universitaire de Tours · FRFédération Francophone de Cancérologie Digestive · FRHôpital Paris Saint-Joseph · FRHôpital Saint-André · FRInserm · FRRoche (France) · FRUniversité d'été de Boulogne-sur-Mer · FR

Funding

institut national du cancer PHRC10_04-02
6 · The paper itself

Abstract

BACKGROUND AND

aimsThere is limited data regarding the role for systemic treatment in patients with Hepatocellular Carcinoma with Child-Pugh B cirrhosis.

methodsPRODIGE 21 was a multicentric prospective non-comparative randomized trial. Patients were randomized to receive sorafenib (Arm A), pravastatin (Arm B), sorafenib-pravastatin (Arm C) combination, or best supportive care (Arm D). Primary endpoint was time to progression (TTP), secondary endpoints included safety and overall survival (OS).

results160 patients were randomized and 157 patients were included in the final analysis. 86% of patients were BCLC C and 55% had macrovascular invasion. The safety profiles of the drugs were as expected. Median TTP was 3.5, 2.8, 2.0 and 2.2 months in arms A, B, C and D, respectively, but analysis was limited by the number of patients deceased without radiological progression (59%). Median OS was similar between the four arms: 3.8 [95% CI: 2.4-6.5], 3.1 [95% CI: 1.9-4.3], 4.0 [95% CI: 3.2-5.5] and 3.5 months [95% CI: 2.2-5.4] in arms A, B, C and D, respectively. Median OS was 4.0 months [95% CI: 3.3-5.5] for patients treated with sorafenib, vs 2.9 months [95% CI: 2.2-3.9] for patients not treated with sorafenib. In patients with ALBI grade 1/2, median OS was 6.1 months [95% CI: 3.8-8.3] in patients treated with sorafenib vs 3.1 months [95% CI: 1.9-4.8] for patients not treated with sorafenib.

conclusionIn the overall Child-Pugh B population, neither sorafenib nor pravastatin seemed to provide benefit. In the ALBI grade 1/2 sub-population, our trial suggests potential benefit of sorafenib. CLINICAL

trial registrationThe study was referenced in clinicaltrials.gov (NCT01357486).

Indexed as

Carcinoma, HepatocellularLiver CirrhosisLiver NeoplasmsAntineoplastic AgentsDrug CombinationsHumansNiacinamidePhenylurea CompoundsPravastatinProspective StudiesSorafenibTreatment OutcomeAntineoplastic AgentsDrug CombinationsNiacinamidePhenylurea CompoundsPravastatinSorafenibALBIChild–PughHCCLiver functionsRandomized clinical trialSorafenib

Identifiers

PMID33420951
OpenAlexW3119318286

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.