Evidence map›Paper›PMID 24614178›Full record

Trial reportPloS one2014

Multicenter phase II study of sequential radioembolization-sorafenib therapy for inoperable hepatocellular carcinoma.

Pierce K H Chow, Donald Y H Poon, Maung-Win Khin, Harjit Singh, Ho-Seong Han, Anthony S W Goh, Su-Pin Choo, Hee-Kit Lai, Richard H G Lo, Kiang-Hiong Tay and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00712790 (Phase I/II Study of SIR-Spheres Plus Sorafenib as First Line Treatment in Patients With Non-Resectable Primary Hepatocellular Carcinoma), which is not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT00712790 phase1 / phase2completednot on this map

Phase I/II Study of SIR-Spheres Plus Sorafenib as First Line Treatment in Patients With Non-Resectable Primary Hepatocellular Carcinoma

TypeinterventionalSponsorSingapore Clinical Research InstituteRan2008 to 2014Enrolled35ConditionsHepatocellular CarcinomaArmsSorafenib, SIR-Spheres
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Applications of Yttrium-90 (OncoTargets and therapy · 2024
    Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. New concepts in embolotherapy of HCC.Medical oncology (Northwood, London, England) · 2017
    Review
  15. Review
  16. Article
  17. Review
  18. Current status of transarterial radioembolization.World journal of radiology · 2016
    Review
  19. Article
  20. 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

15 authors.

Pierce K H ChowNational Cancer Centre, Singapore, Singapore; Singapore General Hospital, Singapore, Singapore; Duke-NUS Graduate Medical School, Singapore, Singapore.
Donald Y H PoonSingapore General Hospital, Singapore, Singapore.
Maung-Win KhinYangon Gastrointestinal and Liver Centre, Yangon, Myanmar.
Harjit SinghSelayang Hospital, Selangor, Malaysia.
Ho-Seong HanSeoul National University Bundang Hospital, Bundang, South Korea.
Anthony S W GohNational Cancer Centre, Singapore, Singapore.
Su-Pin ChooSingapore General Hospital, Singapore, Singapore.
Hee-Kit LaiNational Cancer Centre, Singapore, Singapore.
Richard H G LoNational Cancer Centre, Singapore, Singapore.
Kiang-Hiong TayNational Cancer Centre, Singapore, Singapore.
Teong-Guan LimNational Cancer Centre, Singapore, Singapore.
Mihir GandhiDuke-NUS Graduate Medical School, Singapore, Singapore; Singapore Clinical Research Institute, Singapore, Singapore.
Say-Beng TanDuke-NUS Graduate Medical School, Singapore, Singapore; Singapore Clinical Research Institute, Singapore, Singapore.
Khee-Chee SooNational Cancer Centre, Singapore, Singapore; Singapore General Hospital, Singapore, Singapore; Duke-NUS Graduate Medical School, Singapore, Singapore.
Asia-Pacific Hepatocellular Carcinoma Trials Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe safety and tolerability of sequential radioembolization-sorafenib therapy is unknown. An open-label, single arm, investigator-initiated Phase II study (NCT0071279) was conducted at four Asia-Pacific centers to evaluate the safety and efficacy of sequential radioembolization-sorafenib in patients with hepatocellular carcinoma (HCC) not amenable to curative therapies.

methodsSorafenib (400 mg twice-daily) was initiated 14 days post-radioembolization with yttrium-90 (90Y) resin microspheres given as a single procedure. The primary endpoints were safety and tolerability and best overall response rate (ORR) using RECIST v1.0.Secondary endpoints included: disease control rate (complete [CR] plus partial responses [PR] and stable disease [SD]) and overall survival (OS).

resultsTwenty-nine patients with Barcelona Clinic Liver Cancer (BCLC) stage B (38%) or C (62%) HCC received a median of 3.0 GBq (interquartile range, 1.0) 90Y-microspheres followed by sorafenib (median dose/day, 600.0 mg; median duration, 4.1 months). Twenty eight patients experienced ≥1 toxicity; 15 (52%) grade ≥3. Best ORR was 25%, including 2 (7%) CR and 5 (18%) PR, and 15 (54%) SD. Disease control was 100% and 65% in BCLC stage B and C, respectively. Two patients (7%) had sufficient response to enable radical therapy. Median survivals for BCLC stage B and C were 20.3 and 8.6 months, respectively.

conclusionsThis study shows the potential efficacy and manageable toxicity of sequential radioembolization-sorafenib.

trial registrationClinicalTrials.gov NCT00712790.

Indexed as

AgedCarcinoma, HepatocellularDisease ProgressionDose-Response Relationship, DrugEmbolization, TherapeuticFemaleHumansLiver NeoplasmsMaleMiddle AgedNeoplasm StagingNiacinamidePhenylurea CompoundsQuality of LifeSorafenibTime FactorsNiacinamidePhenylurea CompoundsSorafenibYttrium Radioisotopes

Identifiers

PMID24614178
PMCPMC3948695

What OpenQuestion holds

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LicenceCC BY
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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.