Regorafenib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-REGORAFENIB |
|---|---|
| Type | Drug |
| Aliases | StivargaРегорафеніб |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-CRC DIS-HCC |
| Sources | SRC-ESMO-COLON-2024 SRC-NCCN-COLON-2025 |
Drug Facts
| Class | Multi-kinase inhibitor (VEGFR1-3, TIE2, PDGFR, FGFR, KIT, RET, RAF, BRAF) |
|---|---|
| Mechanism | Oral multi-kinase inhibitor with broad activity vs angiogenic (VEGFR1-3, TIE2), stromal (PDGFR-β, FGFR), and oncogenic (KIT, RET, BRAF, RAF1) kinases. Distinct from sorafenib by inclusion of TIE2 + RET inhibition. Approved for chemo-refractory mCRC, advanced GIST, HCC, and select sarcomas. |
| Typical dosing | 160 mg PO once daily, days 1-21 of each 28-day cycle (3 weeks on, 1 week off). Dose modification protocol: start at 80 mg with weekly escalation to 120-160 mg if tolerated (ReDOS strategy — improves tolerability without efficacy loss). |
| Ukraine registered | True |
| NSZU reimbursed | True |
| Ukraine last verified | 2026-04-27 |
Warnings
- Hepatotoxicity — including fatal hepatic failure (~1-2%)
Notes
CORRECT trial (Grothey 2013): 3L+ chemo-refractory mCRC — regorafenib vs placebo improved mOS 6.4 vs 5.0 mo (HR 0.77). Modest absolute benefit; AE profile substantial — ReDOS dose-escalation strategy (start 80 mg, escalate weekly to 160 mg) improves tolerability with preserved efficacy. CONCUR trial (Asian patients) confirmed activity. Hand-foot skin reaction the dominant tolerability issue — patient education + topical urea prophylaxis essential. Liver function monitoring weekly during cycle 1, then q2 weeks.
Used By
Regimens
REG-REGORAFENIB- Regorafenib monotherapy (CORRECT-style; ReDOS escalation preferred)REG-REGORAFENIB-HCC- Regorafenib (HCC, 2L)