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 (Jun 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
Treatments studied
Other
Cancer type
Osteosarcoma
Sarcoma
Disease stage
Grade: high
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT04698785 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior vegfr inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages