Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

  • STATUS
    Recruiting
  • End date
    May 25, 2024
  • participants needed
    60
  • sponsor
    Sun Yat-sen University
Updated on 25 January 2021

Summary

GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.

Details
Condition Neoadjuvant Therapy, Recurrent Malignant Glioma, Apatinib, Recurrent High Grade Glioma, Carilizumab, induction therapy, neoadjuvant treatment, atan
Treatment PD-1
Clinical Study IdentifierNCT04588987
SponsorSun Yat-sen University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Age 18-70 years old, both male and female
After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma
Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator
KPS score 60
Life expectancy >12 weeks
Adequate organ function defined by
HGB110g/L
WBC3.0109/LNEUT1.5109/L
PLT 75109/L
BIL1.5ULN
ALT and AST2.0ULN
creatinine < 1.5 x ULN or estimated creatinine clearance50ml/minusing the Cockcroft-Gault formula

Exclusion Criteria

Presence of extracranial disease
Previous treatment with a PD-1, PDL-1 or CTLA-4VEGFR targeted therapy
Pregnant or breastfeeding patients
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required
Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection
History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies
Known drug or alcohol abuse
Clear my responses

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