OncoMatch/Clinical Trials/NCT05941325
A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma
Is NCT05941325 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including fruquintinib and Envafolimab for advanced or unresectable locally advanced bone and soft tissue sarcoma.
Treatment: fruquintinib · Envafolimab — Many osteosarcomas are cured with a variety of combined chemotherapy and surgery, but a significant number will still relapse.VEGF promotes an immunosuppressive microenvironment and contributes to immune checkpoint inhibitor resistance in cancer.We aimed to explore the efficacy and safety of fruquintinib combined immunotherapy for bone and soft tissue sarcoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline — advanced or recurrent alveolar soft-tissue sarcoma, clear cell sarcoma, and other bone and soft-tissue sarcomas
Patients with alveolar soft-tissue sarcoma, clear cell sarcoma, and other bone and soft-tissue sarcomas that progressed or recurred after at least previous anthracycline-containing chemotherapy regimens
Cannot have received: anti-PD-1 therapy combined with anti-angiogenesis TKI
Previous treatment with anti-PD-1 or PD-L1 combined with anti-angiogenesis TKI
Cannot have received: radiotherapy
Had received radiotherapy for cancer, surgery, chemotherapy, immunotherapy, and other investigational drugs within 4 weeks prior to treatment
Cannot have received: chemotherapy
Had received radiotherapy for cancer, surgery, chemotherapy, immunotherapy, and other investigational drugs within 4 weeks prior to treatment
Cannot have received: immunotherapy
Had received radiotherapy for cancer, surgery, chemotherapy, immunotherapy, and other investigational drugs within 4 weeks prior to treatment
Cannot have received: investigational drug
Had received radiotherapy for cancer, surgery, chemotherapy, immunotherapy, and other investigational drugs within 4 weeks prior to treatment
Lab requirements
Blood counts
neutrophil absolute value ≥1.5×109/l, platelet ≥100×109/l, hemoglobin concentration ≥9g/dl
Kidney function
serum creatinine ≤1.5×uln, or creatinine clearance rate (ccr)≥60ml/min
Liver function
aspartate aminotransferase and glutamate aminotransferase ≤2.5×uln, bilirubin ≤1.5×uln; ast and alt≤5×uln if liver metastasis is present
Cardiac function
echocardiographic examination of left ventricular ejection fraction < 50%, poor arrhythmia control (including qtcf interval, men > 450 ms, female > 470 ms)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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 qualify