TriangleHEALTH PROFESSIONAL · SOURCE READING
Regorafenib
Source: Primary Liver Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 17, 2025 · Captured 2026-09-09.
Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.
Evidence (regorafenib):
An international, double-blind, placebo-controlled, phase III trial (RESORCE [NCT01774344]) included patients from 21 countries in Asia, Europe, North America, South America, and Australia. The trial enrolled 573 patients with advanced HCC and Child-Pugh class A disease who had tolerated sorafenib but had disease progression. Patients were randomly assigned in a 2:1 ratio to receive either regorafenib (160 mg/day on days 1–21 of a 28-day cycle) or placebo.[17]
An international, double-blind, placebo-controlled, phase III trial (RESORCE [NCT01774344]) included patients from 21 countries in Asia, Europe, North America, South America, and Australia. The trial enrolled 573 patients with advanced HCC and Child-Pugh class A disease who had tolerated sorafenib but had disease progression. Patients were randomly assigned in a 2:1 ratio to receive either regorafenib (160 mg/day on days 1–21 of a 28-day cycle) or placebo.[17]
The median OS was 10.6 months for patients who received regorafenib and 7.8 months for patients who received a placebo (HR, 0.63; 95% CI, 0.50–0.79).[17][Level of evidence A1]
Source links and citations
An international, double-blind, placebo-controlled, phase III trial (RESORCE [NCT01774344]) included patients from 21 countries in Asia, Europe, North America, South America, and Australia. The trial enrolled 573 patients with advanced HCC and Child-Pugh class A disease who had tolerated sorafenib but had disease progression. Patients were randomly assigned in a 2:1 ratio to receive either regorafenib (160 mg/day on days 1–21 of a 28-day cycle) or placebo.[17]
The median PFS was 3.1 months for patients who received regorafenib and 1.5 months for patients who received placebo.
An international, double-blind, placebo-controlled, phase III trial (RESORCE [NCT01774344]) included patients from 21 countries in Asia, Europe, North America, South America, and Australia. The trial enrolled 573 patients with advanced HCC and Child-Pugh class A disease who had tolerated sorafenib but had disease progression. Patients were randomly assigned in a 2:1 ratio to receive either regorafenib (160 mg/day on days 1–21 of a 28-day cycle) or placebo.[17]
The most common grade 3 and 4 regorafenib-related side effects were hypertension (15%), hand-foot syndrome (13%), fatigue (9%), and diarrhea (3%).
Studies cited in this source section
Source citation is not a determination that a study applies to you.
Publication references
Read the original reference and check its publication notices.
Preserved source evidence · Not medical advice