A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC).
- Conditions
- hepatocellular carcinomaliver cancer10019815
- Registration Number
- NL-OMON50334
- Lead Sponsor
- Biocompatibles UK Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
1. Must have signed informed consent prior to any study-related evaluation
2. Must be male or female patients over 18 years of age
3. Must have unresectable HCC confirmed by histology or by non-invasive AASLD10
criteria
4. Must have measurable disease defined as at least one uni-dimensional
measurable lesion by CT
or MRI (according to RECIST 1.1)
5. Must have a Child Pugh score <= 7 points
6. Must have an ECOG Performance Status score of <= 1
7. Must have a Life expectancy of 12 weeks or more
8. Must have be eligible to receive SOC sorafenib
9. Must have Platelet count > 50 x 109/L or > 50% prothrombin activity
10. Must have Hemoglobin >= 8.5 g/dL
11. Must have Bilirubin <= 2.5 mg/dL
12. ALT and AST must be < 5X upper limit of normal
13. Amylase or lipase must be <= 2X upper limit of normal
14. Serum creatinine must be <= 1.5X upper limit of normal
15. INR must be <= 2.0
16. Must not have main PVT (branch portal vein thrombosis is permissible).
17. Must not be eligible for curative treatment (e.g ablation or
transplantation)
18. Must not have a history of previous or concurrent cancer other than HCC
unless treated curatively 5 or more years prior to entry
19. Must not have confirmed presence of extra-hepatic disease with the
exception of lung nodules
and mesenteric or portal lymph nodes <= 2.0 cm each
20. Must not be at risk of hepatic or renal failure
21. Must not have tumor replacement >70% of total liver volume based on visual
estimation by the
investigator OR must not have tumor replacement >50% of total liver volume in
the presence of
albumin <3 g/dL
22. Must not have any history of severe allergy or intolerance to contrast
agents, narcotics sedatives
or atropine that cannot be managed medically
23. Must not have any contraindications to angiography and selective visceral
catheterization
24. Must not have history of organ allograft
25. Must not have any known contraindications to sorafenib including
allergic reaction, pill-swallowing difficulty, evidence of severe or
uncontrolled
systemic diseases, uncontrolled severe hypertension or cardiac
arrhythmias, congestive heartcardiac failure >New York Heart Association (NYHA)
class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, evidence
of torsades de
pointe, 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.
26. Must not be taking any of the following: Rifampicin, St. John*s Wort,
phenytoin, carbamazepine,
phenobarbital, and dexamethasone
27. Must not be taking any other systemic anticancer agent (e.g docetaxel,
doxorubicin, irinotecan etc)
28. Must not be taking substrate agents for CYP2B6 (buproprion,
cyclophosphamide, efavirenz,
ifosfamide, methadone, pacilitaxel, amodiaquine, repaglinide)
29. Must not be taking UGT 1A1 and UGT 1A9 substrates (e.g., irinotecan)
30. Must not be taking P-Gp substrates (e.g., Digoxin)
31. Any prior liver resection must have taken place > 2 months prior to
randomization
32 Treatment with other locoregional therapies (other than study treatment) has
not been planned
for the duration of the clinical study period
33 Has not received any prior external beam radiation treatment to the chest,
liver or abdomen
34. Has not received any prior yttrium-90 microsphere treatment to the liver
35. Prior treatment with transarterial chemoembolization (TACE) or bland
embolization must have
occurred > 2 months prior to randomization and must have been applied to a
treatment field
and/or lobe that is not to be treated under this protocol. For patients with
tumor progression in the treatment field and/or lobe previously treated with
TA(C)E, vessels feeding the tumor(s) must
be assessed for adequate blood flow using angiography (cone beam computerized
tomography (CBCT) strongly recommended), and the TACE or bland embolization
must have been applied >6 months prior to randomization.
36. Has not received any anti-cancer therapy or any treatment with an
investigational agent within
30 days prior to randomization
37. Must not have any adverse effect due
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall Survival (OS) from time of randomization.</p><br>
- Secondary Outcome Measures
Name Time Method