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PLoS One. 2014 Mar 10;9(3):e90909. doi: 10.1371/journal.pone.0090909. eCollection 2014.

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

Author information

  • 1National Cancer Centre, Singapore, Singapore; Singapore General Hospital, Singapore, Singapore; Duke-NUS Graduate Medical School, Singapore, Singapore.
  • 2Singapore General Hospital, Singapore, Singapore.
  • 3Yangon Gastrointestinal and Liver Centre, Yangon, Myanmar.
  • 4Selayang Hospital, Selangor, Malaysia.
  • 5Seoul National University Bundang Hospital, Bundang, South Korea.
  • 6National Cancer Centre, Singapore, Singapore.
  • 7Duke-NUS Graduate Medical School, Singapore, Singapore; Singapore Clinical Research Institute, Singapore, Singapore.



The 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.


Sorafenib (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).


Twenty-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.


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


ClinicalTrials.gov NCT00712790.

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