Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer | Recruiting
Efficacy Evaluation of TheraSphere ... | Recruiting
Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer
STOP-HCC

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Medical Conditions
  • Unresectable Hepatocellular Carcinoma
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01556490
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Device : TheraSphere

Study Arm Groups : Treatment group

Intervention Type
See Interventions above
Primary Outcome Measures
    Overall survival; From time of randomization up to 45 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
390
Participant Inclusion Criteria
    Inclusion Criteria:

    - Signed informed consent prior to any study-related evaluation

    - Male or female patients over 18 years of age

    - Unresectable HCC confirmed by histology or by non-invasive AASLD criteria

    - Measurable disease defined as at least one uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1

    - Child Pugh score ≤ 7 points

    - ECOG Performance Status score of ≤ 1

    - Life expectancy of 12 weeks or more

    - Eligible to receive standard-of-care sorafenib

    - Platelet count of > 50 x 10⁹ or > 50% prothrombin activity

    - Hemoglobin ≥ 8.5 g/dL

    - Bilirubin ≤ 2.5 mg/dL

    - ALT and AST< 5 X upper limit of normal

    - Amylase and lipase ≤ 2X upper limit of normal

    - Serum creatinine ≤ 1.5 X upper limit of normal

    - INR < 2.0

    Exclusion Criteria:

    - Main portal vein thrombosis

    - Eligible for curative treatment (ablation or transplantation)

    - History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry

    - Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ≤ 2.0 cm each

    - Risk of hepatic or renal failure

    - Tumor replacement > 70% of total liver volume based on visual estimation by investigator OR tumor replacement >50% of total liver volume in the presence of albumin <3 mg/dL

    - History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically

    - Contraindications to angiography and selective visceral catheterization

    - Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled hypertension or history of cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis

    - Taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone

    - Taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)

    - Taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)

    - Taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)

    - Taking P-Gp substrates (e.g. Digoxin)

    - Prior liver resection must have taken >2 months prior to randomization

    - Treatment with other locoregional therapies (other than study treatment) has not been planned for the duration of the clinical study period

    - Prior external beam radiation treatment to the liver or abdomen

    - Prior yttrium-90 microsphere treatment to the liver

    - Prior treatment with transarterial chemoembolization (TACE) or bland embolization >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol

    - Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization

    - Adverse effects due to prior therapy unresolved at randomization

    - Prior systemic treatment for the treatment of HCC, including sorafenib

    - Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease

    - Intervention for, or compromise of, the Ampulla of Vater

    - Clinically evident ascites (trace ascites on imaging is acceptable)

    - Pregnancy or breast feeding

    - Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization

    - Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections including patients who are known HIV positive

    - Participation in concurrent clinical trials evaluating treatment intervention(s)
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
London
NW3 2QG
Manchester
M20 4BX
London
W12 0NN
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
GSK Investigational Site
Cambridge
CB2 0QQ
King's College Hospital
London
SE5 9RS
Guildford
GU2 7XX
Sheffield
S10 2SJ
Royal Liverpool University Hospital
Liverpool
England
L69 3GA
Newcastle upon Tyne
NE7 7DN
Trial Contact(s)
Primary Trial Contact
John Saliba
+7 9818816336
Other Trial Contacts
Beth Meyer
+1 4693230532
Countries Recruiting
Belgium, Canada, China, France, Germany, Italy, Korea, Republic of, Netherlands, Singapore, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)
EudraCT Number
Not available for this trial
Funder(s)
  • Biocompatibles UK Ltd
Other Study ID Numbers
TS-103
Sponsor(s)
BTG International Inc.
Key Dates

Recruitment Start Date

Mar 2012

Recruitment End Date

Jul 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

13 Mar 2012

Date updated in source

22 Aug 2017