Single administration of Selective Internal Radiation Therapy versus continuous treatment with sorafeNIB in locally advanced hepatocellular carcinoma (SIRveNIB): study protocol for a phase iii randomized controlled trial

BMC Cancer

Study Protocol

Mihir Gandhi¹  Richard Hoau Gong Lo²  Albert Su Chong Low²  Kiang Hiong Tay²  Jen San Wong³  Peng Chung Cheow³  Brian Kim Poh Goh³  Pierce K. H. Chow⁴  David Chee Eng Ng⁵  Anthony Soon Whatt Goh⁵  Su Pin Choo⁶  Choon Hua Thng⁷  Khee Chee Soo⁸  Say Beng Tan⁹  Wei Ming Liew^1,10 

[1] Biostatistics, Singapore Clinical Research Institute, #02-01, Nanos, 31 Biopolis Way, Singapore, Singapore;Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road, Singapore, Singapore;Tampere Center for Child Health Research, University of Tampere and Tampere University Hospital, Tempere, Finland;Department of Diagnostic Radiology, Singapore General Hospital, Outram Road, Singapore, Singapore;Department of Hepato-pancreato-biliary and Transplant Surgery, Singapore General Hospital, Outram Road, Singapore, Singapore;Department of Hepato-pancreato-biliary and Transplant Surgery, Singapore General Hospital, Outram Road, Singapore, Singapore;Office of Clinical, Academic and Faculty Affairs, Duke-NUS Medical School, 8 College Road, Singapore, Singapore;Program in Translational and Clinical Liver Research, National Cancer Centre Singapore, Singapore, Singapore;Department of Nuclear Medicine and PET, Singapore General Hospital, Outram Road, Singapore, Singapore;Division of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore, Singapore;Division of Oncologic Imaging, National Cancer Centre Singapore, 11 Hospital Drive, Singapore, Singapore;Division of Surgical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore, Singapore;Office of Research, Singapore Health Services, 31 Third Hospital Avenue, #03-03 Bowyer Block C, Singapore, Singapore;Clinical Sciences, Duke-NUS Medical School, 8 College Road, Singapore, Singapore;Project Management, Singapore Clinical Research Institute, #02-01, Nanos, 31 Biopolis Way, Singapore, Singapore;

关键词: Advanced hepatocellular carcinoma;    Liver cancer;    Radioembolisation;    Selective internal radiation therapy;    SIR-Spheres;    Sorafenib;    Systemic therapy;    Asia-Pacific;    Randomized controlled trial;    Phase III;   

DOI  :  10.1186/s12885-016-2868-y

 received in 2016-07-05, accepted in 2016-10-13,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundApproximately 20 % of hepatocellular carcinoma (HCC) patients diagnosed in the early stages may benefit from potentially curative ablative therapies such as surgical resection, transplantation or radiofrequency ablation. For patients not eligible for such options, prognosis is poor. Sorafenib and Selective Internal Radiation Therapy (SIRT) are clinically proven treatment options in patients with unresectable HCC, and this study aims to assess overall survival following either SIRT or Sorafenib therapy for locally advanced HCC patients.MethodsThis investigator-initiated, multi-centre, open-label, randomized, controlled trial will enrol 360 patients with locally advanced HCC, as defined by Barcelona Clinic Liver Cancer stage B or stage C, without distant metastases, and which is not amenable to immediate curative treatment. Exclusion criteria include previous systemic therapy, metastatic disease, complete occlusion of the main portal vein, or a Child-Pugh score of >7. Eligible patients will be randomised 1:1 and stratified by centre and presence or absence of portal vein thrombosis to receive either a single administration of SIRT using yttrium-90 resin microspheres (SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia) targeted at HCC in the liver by the trans-arterial route or continuous oral Sorafenib (Nexavar®, Bayer Pharma AG, Berlin, Germany) at a dose of 400 mg twice daily until disease progression, no further response, complete regression or unacceptable toxicity. Patients for both the Sorafenib and SIRT arms will be followed-up every 4 weeks for the first 3 months and 12 weekly thereafter. Overall survival is the primary endpoint, assessed for the intention-to-treat population. Secondary endpoints are tumour response rate, time-to-tumour progression, progression free survival, quality of life and down-staging to receive potentially curative therapy.DiscussionDefinitive data comparing these two therapies will help to determine clinical practice in the large group of patients with locally advanced HCC and improve outcomes for such patients.Trial registrationClinicalTrials.gov identifier, NCT01135056, first received 24, May 2010.

【 授权许可】

CC BY   
© The Author(s). 2016