AzTrials
AzTrials

Hepatocellular CarcinomaPhase 1/2NCT00712790

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

A Phase 1/2 study testing Sorafenib and SIR-Spheres in people with Hepatocellular Carcinoma, run by Singapore Clinical Research Institute at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sorafenib and SIR-Spheres
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
5 sitesin 4 countries
Study dates
Jun 2008to Apr 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • 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.

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

Burma1 site

  • Yangon GI & Liver Centre

    Yangon

Other trials in Burma

Malaysia1 site

  • Selayang Hospital

    Kuala Selangor

Other trials in Malaysia

South Korea1 site

  • Seoul National University Bundang Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
Sorafenib, SIR-Spheres
Keywords
First line treatment for Hepatocellular Carcinoma
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    Also called BAY 43-9006

    Tablet, 400mg orally, twice daily

  • SIR-SpheresRadiation

    Also called Yttrium-90 Microspheres

    one time treatment and capped at 3.0 Gbq

Study groups in NCT00712790
Study groupRoleWhat they receive
Sequential Radioembolization-SorafenibExperimentalSorafenib (400 mg twice-daily) was initiated 14 days post-radioembolization with yttrium-90 (Y) resin microspheres given as a single procedure.
Receives: Drug: Sorafenib; Radiation: SIR-Spheres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity and safety

    Measured: 2 years

  2. Tumour response rate (liver ± any site).

    Measured: 2 years

Secondary outcomes (6)

  1. Progression free survival at any site.

    Measured: 2 years

  2. Progression free survival in the liver.

    Measured: 2 years

  3. Survival

    Measured: 2 years

  4. Hepatic and extra-hepatic recurrence rate.

    Measured: 2 years

  5. Quality of life.

    Measured: 2 years

  6. Rate of downstaging to surgical resection or ablative therapy.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJun 2009
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00712790
Sponsor's protocol ID
NMRC - AHCC05
Status last verified
Jan 2016
First submitted
7 Jul 2008
Last updated
6 Jan 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 24614178

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sorafenib and SIR-Spheres in people with Hepatocellular Carcinoma, run by Singapore Clinical Research Institute at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Singapore, Burma, Malaysia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity and safety (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00712790, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in