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Trial record 13 of 46 for:    SIR-Spheres

Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-resectable Primary Hepatocellular Carcinoma (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00712790
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : January 6, 2016
National Medical Research Council (NMRC), Singapore
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Sirtex Medical
Information provided by (Responsible Party):
Pierce K.H.Chow, Singapore General Hospital

Tracking Information
First Submitted Date  ICMJE July 7, 2008
First Posted Date  ICMJE July 10, 2008
Last Update Posted Date January 6, 2016
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
  • Toxicity and safety [ Time Frame: 2 years ]
  • Tumour response rate (liver ± any site). [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00712790 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
  • Progression free survival at any site. [ Time Frame: 2 years ]
  • Progression free survival in the liver. [ Time Frame: 2 years ]
  • Survival [ Time Frame: 2 years ]
  • Hepatic and extra-hepatic recurrence rate. [ Time Frame: 2 years ]
  • Quality of life. [ Time Frame: 2 years ]
  • Rate of downstaging to surgical resection or ablative therapy. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-resectable Primary Hepatocellular Carcinoma (HCC)
Official Title  ICMJE Phase I/II Study of SIR-Spheres Plus Sorafenib as First Line Treatment in Patients With Non-Resectable Primary Hepatocellular Carcinoma
Brief Summary

This Phase I/II trial will evaluate the safety and activity of chemo-radiotherapy comprising a regimen of Sorafenib chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), for first-line treatment of patients with primary hepatocellular carcinoma (HCC) in whom surgical resection is not feasible.

This study is designed as a prelude to a planned future randomised comparative study that will compare the efficacy of Sorafenib plus SIR-Spheres versus Sorafenib alone, in this patient population.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Sorafenib
    Tablet, 400mg orally, twice daily
    Other Name: BAY 43-9006
  • Radiation: SIR-Spheres
    one time treatment and capped at 3.0 Gbq
    Other Name: Yttrium-90 Microspheres
Study Arms  ICMJE Experimental: Sequential Radioembolization-Sorafenib
Sorafenib (400 mg twice-daily) was initiated 14 days post-radioembolization with yttrium-90 (Y) resin microspheres given as a single procedure.
  • Drug: Sorafenib
  • Radiation: SIR-Spheres
Publications * Chow PK, Poon DY, Khin MW, Singh H, Han HS, Goh AS, Choo SP, Lai HK, Lo RH, Tay KH, Lim TG, Gandhi M, Tan SB, Soo KC; Asia-Pacific Hepatocellular Carcinoma Trials Group. Multicenter phase II study of sequential radioembolization-sorafenib therapy for inoperable hepatocellular carcinoma. PLoS One. 2014 Mar 10;9(3):e90909. doi: 10.1371/journal.pone.0090909. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2009)
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2008)
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unresectable HCC with or without systemic metastases.
  • Willing, able and mentally competent to provide written informed consent prior to any testing under this study protocol, including screening tests and evaluations that are not considered to be part of the subject's routine care.
  • Aged 18 years or older of either gender and any race, religion or socioeconomic group.
  • Unequivocal diagnosis of primary HCC (as defined above)
  • HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation, consistent with the practice of the clinical trial centre.
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with spiral CT scan.
  • ECOG performance status 0 - 1.
  • Adequate haematological, renal and hepatic function as follows:
  • Leukocytes ≥ 2,500/μL
  • Absolute Neutrophil Count ≥ 1,500/μL
  • Platelets ≥ 50,000/μL
  • Haemoglobin > 9.5 g/dL
  • Total bilirubin ≤ 2.0 mg/dL (SIR-Spheres should not be administered as a whole liver treatment if the total bilirubin is > 2X the institutional upper limit of normal).
  • INR ≤ 2.0
  • ALP ≤ 5 x institutional upper limit of normal
  • AST / ALT ≤ 5 x institutional upper limit of normal
  • Albumin ≥ 2.5 g/dL
  • Creatinine ≤ 2.0 mg/dL
  • The blood results must be less than 29 days old at the time of confirming patient eligibility to receive protocol treatment.
  • Life expectancy of at least 3 months without any active treatment. This is defined as a patient who has OKUDA I or II inoperable HCC.
  • Suitable for protocol treatment as determined by clinical assessment undertaken by the Investigator.
  • Female patients must be either postmenopausal or, if premenopausal, must have a negative pregnancy test and agree to use two forms of contraception if sexually active during their study participation.
  • Male patients must be surgically sterile, or if sexually active and having a pre-menopausal female partner then must be using an acceptable form of contraception.
  • Hepatic arterial anatomy suitable for implantation of SIR-Spheres, as assessed by hepatic angiogram.
  • Lung shunt fraction less than or equal to 20% as assessed by a Tc-99m macroaggregated albumin liver to lung breakthrough scan.

Exclusion Criteria:

  • Had previous external beam radiation therapy to the liver.
  • Any ascites or other clinical signs of liver failure, on physical examination.
  • Abnormal synthetic and excretory liver function tests (LFTs) as determined by serum albumin (must be < 2.5 g/dL) and total bilirubin (must be > 2.0 mg/dL), respectively.
  • Tumours amenable to surgical resection for cure at presentation.
  • Greater than 20% lung shunting of the hepatic artery blood flow determined by Tc-99 MAA scan.
  • Pre-assessment angiogram and Tc-99 MAA scan that demonstrates significant and uncorrectable activity in the stomach, pancreas or bowel.
  • Been treated with Capecitabine within the previous 8 weeks, or who will be treated with Capecitabine within 8 weeks of treatment with SIR-Spheres, due to the possible risk of potentiating or causing liver dysfunction.
  • Complete main portal vein thrombosis.
  • Subjects who have had hepatic artery directed therapy.
  • Subjects who have had prior chemotherapy or other medical agents used to treat hepatocellular carcinoma.
  • Prior external hepatic radiation therapy for HCC, or any other concomitant therapy for HCC or any investigational agent planned while on this protocol.
  • Subjects with inferior vena cava (IVC) tumour thrombus or invasion
  • Currently receiving any other investigational agents for the treatment of their cancer.
  • Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
  • Presence of clinical signs of CNS metastases due to their poor prognosis and because progressive neurologic dysfunction would confound the evaluation of neurologic and other adverse events.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (except viral hepatitis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any of the following contraindications to angiography and selective visceral catheterization:

    • Bleeding diathesis, not correctable by the standard forms of therapy.
    • Severe peripheral vascular disease that would preclude arterial catheterization.
    • Portal hypertension with hepatofugal flow as documented on baseline spiral CT scan.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres.
  • Inability or unwillingness to understand or sign a written informed consent document (non English-speaking patients may use an interpreter).
  • Female subjects who are pregnant or currently breastfeeding.
  • For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the Investigator, during the study. The rhythm method is not to be used as the sole method of contraception.
  • For male subjects, unwillingness to practice effective contraception (as defined by the Investigator) while taking part in this study, because the effect of the SIR-Spheres treatment on sperm or upon the development of an unborn child are unknown.
  • Current enrolment in any other investigational drug or device study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Malaysia,   Myanmar,   Singapore
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00712790
Other Study ID Numbers  ICMJE NMRC - AHCC05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierce K.H.Chow, Singapore General Hospital
Study Sponsor  ICMJE Singapore Clinical Research Institute
Collaborators  ICMJE
  • National Medical Research Council (NMRC), Singapore
  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
  • Sirtex Medical
Investigators  ICMJE
Study Chair: Pierce Chow, Phd SGH
PRS Account Singapore Clinical Research Institute
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP