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Type(s) of Cancer
Liver
Study Phase
Phase 3
Study Completion Date
2015-05-21
NCT01015833Uploaded 10-21-2022
Access via NCI by Request
PDS UID: nci-data-499
Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
Provider Information
Provider Data DescriptionDataset NCT01015833-D1-Dataset.csv (nctn_d1) is the only dataset associated with PubMed ID 31486832. This dataset contains the information for the entire primary analysis.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with liver cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
ConditionsAdvanced Adult Hepatocellular Carcinoma
Recurrent Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v7
Stage IIIA Hepatocellular Carcinoma AJCC v7
Stage IIIB Hepatocellular Carcinoma AJCC v7
Stage IIIC Hepatocellular Carcinoma AJCC v7
Stage IV Hepatocellular Carcinoma AJCC v7
Stage IVA Hepatocellular Carcinoma AJCC v7
Stage IVB Hepatocellular Carcinoma AJCC v7
Unresectable Hepatocellular Carcinoma
Intervention TypeDrug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Drug: Sorafenib Tosylate
Drug(s)Drug: Doxorubicin Hydrochloride
Drug: Sorafenib Tosylate
Total Enrolled356
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm I (doxorubicin hydrochloride, sorafenib tosylate) - Experimental
Arm II (sorafenib tosylate) - Experimental
Secondary IDNCI-2011-01989
PubMed (PMID)35484400
31486832
Collaborator(s)N/A
Region(s)United States
Canada
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01015833-D1
Data DictionaryNCT01015833-D1-Data-Dictionary_2.pdf
DATANCT01015833-D1-Dataset_1.csv
OTHERREADME.pdf
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