Evidence map›Paper›PMID 34297268›Full record

Trial reportDigestive diseases and sciences2022

Priming of Sorafenib Prior to Radiofrequency Ablation Does Not Increase Treatment Effect in Hepatocellular Carcinoma.

Bruno Bockorny, Andrea J Bullock, Thomas A Abrams, Salomao Faintuch, David C Alsop, S Nahum Goldberg, Muneeb Ahmed, Rebecca A Miksad

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00813293 (Randomized, Double-Blind, Placebo-Controlled, Phase II Trial Of Short Course Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 37% 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.

NCT00813293 phase2completednot on this map

Randomized, Double-Blind, Placebo-Controlled, Phase II Trial Of Short Course Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized (3.5 to 7cm) Hepatocellular Cancer

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2009 to 2013Enrolled20ConditionsHepatocellular CancerArmsSorafenib, radiofrequency ablation
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. New insights into mechanisms and interventions of locoregional therapies for hepatocellular carcinoma.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024
    Article
  3. Review
  4. 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

8 authors at 3 institutions in 2 countries.

Bruno Bockorny *Beth Israel Deaconess Medical Center, Boston, MA, USA. bbockorn@bidmc.harvard.edu.ORCID 0000-0002-9162-1560
Andrea J Bullock *Beth Israel Deaconess Medical Center, Boston, MA, USA.
Thomas A AbramsHarvard Medical School, Boston, MA, USA.
Salomao FaintuchBeth Israel Deaconess Medical Center, Boston, MA, USA.
David C AlsopBeth Israel Deaconess Medical Center, Boston, MA, USA.
S Nahum GoldbergBeth Israel Deaconess Medical Center, Boston, MA, USA.
Muneeb AhmedBeth Israel Deaconess Medical Center, Boston, MA, USA.
Rebecca A MiksadBoston Medical Center, Boston University, Boston, MA, USA.
Beth Israel Deaconess Medical Center · USBoston University · USHarvard University · US

Funding

National Institutes of Health (US) K23CA139005
6 · The paper itself

Abstract

backgroundPreclinical studies have shown that modulation of the tumor microvasculature with anti-angiogenic agents decreases tumor perfusion and may increase the efficacy of radiofrequency ablation (RFA) in hepatocellular carcinoma (HCC). Retrospective studies suggest that sorafenib given prior to RFA promotes an increase in the ablation zone, but prospective randomized data are lacking.

aimsWe conducted a randomized, double-blind, placebo-controlled phase II trial to evaluate the efficacy of a short-course of sorafenib prior to RFA for HCC tumors sized 3.5-7 cm (NCT00813293).

methodsTreatment consisted of sorafenib 400 mg twice daily for 10 days or matching placebo, followed by RFA on day 10. The primary objectives were to assess if priming with sorafenib increased the volume and diameter of the RFA coagulation zone and to evaluate its impact on RFA thermal parameters. Secondary objectives included feasibility, safety and to explore the relationship between tumor blood flow on MRI and RFA effectiveness.

resultsTwenty patients were randomized 1:1. Priming with sorafenib did not increase the size of ablation zone achieved with RFA and did not promote significant changes in thermal parameters, although it significantly decreased blood perfusion to the tumor by 27.9% (p = 0.01) as analyzed by DCE-MRI. No subject discontinued treatment owing to adverse events and no grade 4 toxicity was observed.

conclusionPriming of sorafenib did not enhance the effect of RFA in intermediate sized HCC. Future studies should investigate whether longer duration of treatment or a different antiangiogenic strategy in the post-procedure setting would be more effective in impairing tumor perfusion and increasing RFA efficacy.

Indexed as

Carcinoma, HepatocellularCatheter AblationLiver NeoplasmsRadiofrequency AblationHumansNiacinamidePhenylurea CompoundsProspective StudiesRetrospective StudiesSorafenibTreatment OutcomeNiacinamidePhenylurea CompoundsSorafenibDCE-MRIHCCHepatocellular carcinomaRadiofrequency ablationSorafenib

Identifiers

PMID34297268
OpenAlexW3184672870

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.