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Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM
Sponsor: Ascletis Pharmaceuticals Co., Ltd.
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.
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate Safety and Efficacy pf ASC40 Tablets Combined With Bevacizumab in Subjects With Recurrent Glioblastoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2022-01-21
Completion Date
2025-06
Last Updated
2024-10-31
Healthy Volunteers
No
Conditions
Interventions
ASC40 tablets
ASC40 tablets administered orally once daily
Placebo tablets
Placebo administered orally once daily.
Bevacizumab
Bevacizumab once every 2 weeks, intravenous drip.
Locations (1)
Beijing Tiantan Hospital，Capital Medical University
Beijing, Beijing Municipality, China