Study Objectives Primary Objective: To assess the efficacy of regorafenib in patients with immediate or advanced stage HCC Secondary objective: To assess the safety of regorafenib in patients with immediate or advanced stage HCC~Study Design This is a multicenter, retrospective, real-world study that will collect data from patients treated with regorafenib at medical centers in China.~Data Collection 3.1 Screening Period~The study procedures to be performed at screening include:~. Determine eligible subjects according to the inclusion/exclusion criteria and document the results.~. Collect demographic characteristics (eg, age, sex, weight, BMI, and ECOG score);~. Collect past medical history;~. Collect primary tumor site;~. Collect information on prior treatments: all treatments received since diagnosis of advanced HCC, including each treatment regimen (including first-line therapy), start and end date, duration, best response;~. Collect information on liver function and ECOG score prior to the first dose of regorafenib;~. Collect results of laboratory tests performed prior to and after the first dose of regorafenib, including haematology, biochemistry and genetic testing (if any);~. Collect imaging data: the last imaging procedure performed prior to the first dose of regorafenib, such as CT, PET-CT, MRI, and whole-body bone scan (with at least 1 measurable lesion); and information related to metastases (such as metastases to lymph node, bone and/or lung).~3.2 Data Review Period of Regorafenib Treatment~The following information obtained during each cycle of regorafenib will be collected retrospectively:~. Liver function and ECOG score obtained prior to each dose (ie., the first day of each cycle) of regorafenib;~. Initial dose of regorafenib;~. Timing and method of dose adjustment, and adjusted doses;~. Final daily dose of regorafenib;~. Best response, time to best response, and number of treatment cycles;~. Imaging findings (including metastatic sites) related to response evaluation;~. Hematology laboratory tests (related to the underlying disease, tumor progression, and ADR);~. Any adverse reaction and corresponding CTCAE grade;~. Interrupted or discontinued treatment;~. The most recent laboratory tests (or alternative doctor's advice and tests) performed prior to the first day of each treatment cycle, including but not limit to hematology and biochemistry.~3.3 Progression and Survival Data Collection Period~The following information obtained during each cycle of regorafenib will be collected retrospectively:~. Time to progression~. Pattern of progression~. Subsequent treatment regimen, dose, number of cycles, efficacy;~. Survival status, time of death or last follow-up.~4. Study Drug Generic name: Regorafenib Tablets Trade name: Stivarga® English name: Regorafenib Tablets~Dosage strength: 40 mg tablet Dosage form: Tablets Description: Oval tablets with pale-pink film coat Label dose and mode of administration: Recommended dosage is 160 mg, once daily for the first 21 days of each 28-day cycle. A minimum dose of 80 mg/day and a maximum dose of 160 mg/day are recommended.
This is a non-interventional observational study with the primary objective of assessing the efficacy of regorafenib in patients with immediate or advanced stage HCC.