Anlotinib Combined With Dose-dense Temozolomide for the First Recurrent or Progressive Glioblastoma After STUPP Regimen
NCT04547855 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2020-09-14
Summary
Currently,6 cycles of Temozolomide adjuvant chemotherapy after concurrent radiotherapy and Temozolomide chemotherapy(STUPP regimen)for newly diagnosed postoperative GBM can increase the 2-year and 5-year overall survival rates of patients to 26.5% and 9.8%, respectively. However, most patients are still unable to avoid tumor recurrence and death.Anlotinib is an efficient multi-target tyrosine kinase inhibitor (TKI) that effectively block the migration and proliferation of endothelial cells and reduce tumor microvascular density by targeting VEGFRs, FGFRs, PDGFRs. It has been proved to be safe and effective in advanced lung cancer(including NSCLC,SCLC)after second-line standard chemotherapy failure,and advanced soft tissue sarcoma after anthracycline-containing chemotherapy failure.Here, we prepared to evaluate whether the combination of dose-dense Temozolomide and Anlotinib can preferably improved survival of the first recurrent or progressive GBM after STUPP regimen.
Conditions
Interventions
- DRUG
-
anlotinib combined with dose-dense temozolomide
Temozolomide Capsule 150mg, p.o., qd, d1-7,15-21,4 weeks one cycle; Anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.
Sponsors & Collaborators
-
The First Affiliated Hospital of Nanchang University
collaborator OTHER -
Yonggao Mou
lead OTHER
Principal Investigators
-
QUN-YING YANG, MD · Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-11
- Primary Completion
- 2022-09-11
- Completion
- 2023-03-11
Countries
- China
Study Locations
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