OncoMatch/Clinical Trials/NCT04698785
Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients
Is NCT04698785 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Treatment by regorafenib and best supportive care for bone sarcoma.
Treatment: Treatment by regorafenib and best supportive care — This is a multicenter phase II study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or at relapse. Patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion. Progression free rate (PFR) data will be collected and analysed for all included patients to evaluate if regorafenib + BSC can be considered as an interesting treatment for further investigations in this indication.
Check if I qualifyExtracted eligibility criteria
Cancer type
Osteosarcoma
Sarcoma
Disease stage
Grade: high
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: vegfr inhibitor (regorafenib, sunitinib, sorafenib, pazopanib, bevacizumab)
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 Giga/l; Platelets ≥ 100 Giga/l; Haemoglobin ≥ 9 g/dl
Kidney function
Serum creatinine ≤ 1.5 x ULN; GFR ≥ 30 ml/min/1.73m2 (MDRD formula); Spot urine must not show ≥ 1 '+' protein or 24-hour urine collection must show total protein excretion < 1000 mg/24 hours
Liver function
AST and ALT ≤ 2.5 x ULN (≤ 5.0 × ULN for patients with liver involvement); Bilirubin ≤1.5 X ULN; Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN in patient with liver involvement); If Alkaline phosphatase > 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and/or GGT < 1.5 x ULN.
Cardiac function
LVEF ≥ 50%; No congestive heart failure ≥ NYHA class 2; No myocardial infarction < 6 months prior; No cardiac arrhythmias requiring therapy (beta blockers or digoxin permitted); No unstable or new-onset angina within last 3 months; No uncontrolled hypertension (systolic > 150 mm Hg or diastolic > 90 mm Hg despite optimal treatment); No arterial or venous thrombotic or embolic events within last 6 months
Adequate bone marrow and organ function defined by the following laboratory results: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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