{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["sorafenib","doxorubicin"]],"indication":"advanced hepatocellular carcinoma","name":"CALGB 80802","nct_id":"NCT01015833","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=calgb-80802-nct01015833. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive doxorubicin hydrochloride IV on day 1 and sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.","label":"Arm I (doxorubicin hydrochloride, sorafenib tosylate)","type":"EXPERIMENTAL"},{"description":"Patients receive sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","label":"Arm II (sorafenib tosylate)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2018-08-15","type":"ACTUAL"},"conditions":["Advanced 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"],"enrollment":{"count":356,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Doxorubicin Hydrochloride","otherNames":["5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)","ADM","Adriacin","Adriamycin","Adriamycin Hydrochloride","Adriamycin PFS","Adriamycin RDF","ADRIAMYCIN, HYDROCHLORIDE","Adriamycine","Adriblastina","Adriblastine","Adrimedac","Chloridrato de Doxorrubicina","DOX","DOXO-CELL","Doxolem","Doxorubicin HCl","Doxorubicin.HCl","Doxorubin","Farmiblastina","FI 106","FI-106","hydroxydaunorubicin","Rubex"],"type":"DRUG"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Pharmacogenomic Study","otherNames":["PHARMACOGENOMIC"],"type":"OTHER"},{"name":"Sorafenib Tosylate","otherNames":["BAY 43-9006 Tosylate","BAY 54-9085","Nexavar","sorafenib"],"type":"DRUG"}],"last_update":"2026-06-24","lead_sponsor":"National Cancer Institute (NCI)","official_title":"Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2015-05-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival","timeFrame":"Up to 3 years"}],"references":[{"citation":"Quintanilha JCF, Geyer S, Etheridge AS, Racioppi A, Hammond K, Crona DJ, Pena CE, Jacobson SB, Marmorino F, Rossini D, Cremolini C, Sanoff HK, Abou-Alfa GK, Innocenti F. KDR genetic predictor of toxicities induced by sorafenib and regorafenib. Pharmacogenomics J. 2022 Dec;22(5-6):251-257. doi: 10.1038/s41397-022-00279-3. Epub 2022 Apr 28.","pmid":"35484400","type":"DERIVED"},{"citation":"Abou-Alfa GK, Shi Q, Knox JJ, Kaubisch A, Niedzwiecki D, Posey J, Tan BR Jr, Kavan P, Goel R, Lammers PE, Bekaii-Saab TS, Tam VC, Rajdev L, Kelley RK, El Dika I, Zemla T, Potaracke RI, Balletti J, El-Khoueiry AB, Harding JJ, Suga JM, Schwartz LH, Goldberg RM, Bertagnolli MM, Meyerhardt J, O'Reilly EM, Venook AP. Assessment of Treatment With Sorafenib Plus Doxorubicin vs Sorafenib Alone in Patients With Advanced Hepatocellular Carcinoma: Phase 3 CALGB 80802 Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1582-1588. doi: 10.1001/jamaoncol.2019.2792.","pmid":"31486832","type":"DERIVED"}],"start_date":{"date":"2010-02-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer","url":"https://clinicaltrials.gov/study/NCT01015833"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/calgb-80802-nct01015833"}