Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM

  • STATUS
    Recruiting
  • End date
    Sep 16, 2023
  • participants needed
    180
  • sponsor
    Ascletis Pharmaceuticals Co., Ltd.
Updated on 10 July 2022

Summary

This is a randomized, double-blind, controlled and multi-center Phase III clinical trial to evaluate the safety and efficacy of ASC40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. After standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.

Details
Condition Recurrent Glioblastoma
Treatment bevacizumab, Placebo Tablets, ASC40 tablets
Clinical Study IdentifierNCT05118776
SponsorAscletis Pharmaceuticals Co., Ltd.
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Age ≥18 years old, both male and female
\. Histologically confirmed glioblastoma
\. Patients with glioblastoma who have failed standard treatment (surgery, Stupp regimen), were diagnosed by MRI and evaluated by RANO standard to support the first recurrence. Stupp regimen needs to complete at least 6 medication cycles

Exclusion Criteria

\. Use low molecular weight heparin and warfarin within 35 days before randomization
\. Arterial or venous thrombosis (such as cerebral infarction, myocardial infarction, venous thrombosis of lower limbs, arterial embolism of lower limbs, pulmonary embolism, etc.) occurred within 6 months before randomization
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