Overview

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

Status:
Not yet recruiting
Trial end date:
2023-09-16
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Criteria
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