RecruitingPhase 2

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

China20 participantsStarted 2023-04-01

Plain-language summary

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.

Who can participate

Age range12 Years – 70 Years

SexALL

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Inclusion criteria

✓. Neutrophil absolute value ≥1.5×109/L, platelet ≥100×109/L, hemoglobin concentration ≥9g/dL;
✓. Liver function (aspartate aminotransferase and glutamate aminotransferase ≤2.5×ULN, bilirubin ≤1.5×ULN; AST and ALT≤5×ULN if liver metastasis is present);
✓. Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance rate (CCr)≥60ml/min);
✓. Coagulation, international standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN;
✓. Thyroid function, thyroid stimulating hormone (TSH) ≤ the upper normal value (ULN); If abnormal, T3 and T4 levels should be examined, and if T3 and T4 levels are normal, they can be selected;

Exclusion criteria

✕. Known human immunodeficiency virus (HIV) infection;
✕. A known history of clinically significant liver disease, including viral hepatitis \[a known hepatitis B virus (HBV) carrier must exclude active HBV infection, i.e., positive HBV DNA (\> 1×104 copies /mL or \> 2000 IU/ mL);
✕. Known hepatitis C virus infection (HCV) with HCV RNA positive (\> 1×103 copies /mL), or other hepatitis, cirrhosis\];

What they're measuring

Progression-Free-Survival

Timeframe: assessed up to 1 year

Trial details

NCT IDNCT05941325

SponsorShanghai 6th People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma trials