ASC40 tablets: ASC40 tablets administered orally once daily
Placebo tablets: Placebo administered orally once daily.
Bevacizumab: Bevacizumab once every 2 weeks, intravenous drip.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 1\. Age ≥18 years old, both male and female;
* 2\. Histologically confirmed glioblastoma;
* 3\. 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:
* 1\. Use low molecular weight heparin and warfarin within 35 days before randomization;
* 2\. 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
Primary outcome measure(s)
Progression-free survival — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months The time of progression or death from any cause in randomly grouped diseases (whichever comes first) was compared with the control group (evaluated by Independent Imaging Evaluation Committee \[IRC\])
Total survival — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months the time from random grouping to death, compared with the control group.
Trial sites (1)
Facility
City
Region
Status
Beijing Tiantan Hospital，Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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