Phase 3
N=235
Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Hepatocellular Carcinoma · Unresectable Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01004978 ↗Enrolled (actual)
235
Serious AEs
48.6%
Results posted
Feb 2023
Primary outcome: Primary: Progression-free Survival (PFS) — 9.3; 8.4 months — p=0.4
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cisplatin (Drug); Computed Tomography (Procedure); Doxorubicin Hydrochloride (Drug); Doxorubicin-Eluting Beads (Drug); Laboratory Biomarker Analysis (Other); Magnetic Resonance Imaging (Procedure); Mitomycin (Drug); Pharmacological Study (Other); Placebo Administration (Other); Sorafenib Tosylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
9.3; 8.4 | 0.4 |
| SECONDARY Overall Survival (OS) |
19.8; 19.9 | 0.76 |
| SECONDARY Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression |
6.83; 5.6 | — |
| SECONDARY Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression |
8.5; 7.8 | — |
Summary
This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Kinase inhibitors, such as sorafenib tosylate may stop the growth of tumor cells by blocking the action of an abnormal protein that signals cancer cells to multiply. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.
Eligibility Criteria
Inclusion Criteria
- Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
- Histologically confirmed
- Magnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP)
- AFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI
- Patients must have hepatocellular carcinoma (HCC) limited to the liver; there must be no clinical or radiographic evidence of extrahepatic HCC
- Portal lymphadenopathy IS permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy
- Staging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration
- Patients must have measurable disease constituting = 50,000/mm^3
- Patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
- Patients must have no clinical signs of heart failure and meet New York Heart Association functional classification I or II defined as:
- Class I - patients with no limitation of activities; they suffer no symptoms from ordinary activities
- Class II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have a life expectancy of at least 3 months
- Patients must not be known to be human immunodeficiency virus (HIV) positive
- Patients must not have other uncontrolled intercurrent illnesses excluding HBV or HCV, including, but not limited to: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/addictive disorders that would limit compliance with study requirements
- Uncontrolled hypertension is defined as optimally treated baseline blood pressure that exceeds 150/90 mm Hg
- Patients must not be taking cytochrome P450 enzyme inducing drugs
- Age >= 18 years
- Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
- Patients must not have an allergy to iodine or gadolinium contrast that cannot be safely controlled with premedication
- Patient must be able to swallow pills, as study medications cannot be crushed
Data sourced from ClinicalTrials.gov (NCT01004978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.