E1208 – A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion
E1208 is a randomized, double-blind, placebo-controlled, multicenter, phase 3 study comparing the effect of chemoembolization combined with oral sorafenib tosylate (400 mg twice daily) vs. chemoembolization alone on progression-free survival in patients with unresectable hepatocellular carcinoma (HCC). Secondary outcome measures include overall survival and toxicity.
Physician and Research Staff Educational Materials:
These materials are intended for promotional use among health care professionals and are NOT intended for use as patient educational materials.
- Trial Overview: detailed overview of the protocol, disease state, and rationale for transarterial chemoembolization in advanced hepatocellular carcinoma.
- Pocket Reference Card: trial schema, study objectives, and eligibility requirements on a pocket-sized card for easy reference when consulting with patients in the office or on rounds.
- Study Summary for Physicians: schema, study objectives, eligibility criteria, and other key information about the study.
- Physician FAQs: questions and answers on treatment, eligibility criteria, and potential enrollment issues.
- Physician Fact Sheet: schema, study objectives, eligibility criteria, and other key information about the study.
Patient Educational Materials:
- Study Summary for Patients: study objectives, eligibility criteria, and a simplified schema in lay language to provide a more visual description of the trial to patients.
Participating sites should note that the Central Institutional Review Board (CIRB) has approved this document. For sites utilizing local IRBs, please submit this in accordance with your local IRB policies prior to use.
Information and Assistance from the National Cancer Institute:
- Trained information specialists at the NCI are available to answer cancer-related questions from patients, family members or friends, health care providers, and researchers. Visit the NCI’s Cancer Information Service webpage for contact instructions, including telephone, live chat, email, and mail.
Additional Information on ClinicalTrials.gov: Displayed below is an interactive view of the study record as it appears in the government registry. If you are experiencing technical difficulties with this view, visit clinicaltrials.gov and search for record NCT01004978.