Clinical Study of Apatinib Combined With Temozolomide in the Treatment of Uncontrolled or Repeated High-grade Gliomas
|ClinicalTrials.gov Identifier: NCT04253873|
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|High-grade Gliomas||Drug: Apatinib||Phase 2|
Temozolomide combined with concurrent radiotherapy, followed by 6 cycles of temozolomide adjuvant chemotherapy, can prolong the patient's survival, and the 2-year survival rate has increased from 10.4% to 26.5%. Great progress has been made, but the prognosis for glioma patients remains poor. For patients with poor-quality high-grade gliomas, more effective new treatments are urgently needed to achieve the purpose of survival benefit.
Targeting VEGFs to inhibit tumor angiogenesis has shown good efficacy in a variety of tumors including colon cancer, gastric cancer, lung cancer, liver cancer and breast cancer. However, for gliomas, anti-tumor angiogenesis drugs can improve patient OS Evidence related to PFS is still scarce. Compared with other targeted drugs with multiple kinase targets, apatinib has not only an advantage in price but also less side effects. Therefore, based on relevant data from previous studies, a basic and clinical study of this apatinib combined with temozolomide for high-grade gliomas was performed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Apatinib Combined With Temozolomide in the Treatment of Uncontrolled or Repeated High-grade Gliomas|
|Actual Study Start Date :||December 16, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Apatinib mesylate + temozolomide
Apatinib mesylate tablets (0-14 days, 500 mg, qd), one week apart, then temozolomide (150mg/m2, 5 days);Every 28 days is a cycle, the drug until the disease progress, the toxicity of intolerable.
Apatinib mesylate (0-14 days, 500 mg, qd), taken half an hour after a meal (the daily dose should be as much as possible), one week apart, and then given temozolomide (150mg/m2 for 5 Days); every 28 days is a cycle, medication to disease progression, intolerable toxicity, etc.
Other Name: temozolomide
- 6-month PFS rate [ Time Frame: up to 1 year ]Proportion of progression-free survival up to 6 months
- Progression-free survival (PFS) [ Time Frame: up to 1 year ]Refers to the date from the random date to the first occurrence of disease progression or death from any cause, whichever occurs first.
- Overall survival (OS) [ Time Frame: up to 1 year ]Means from random date to the date of death for any reason
- Objective response rate (ORR) [ Time Frame: up to 1 year ]Refers to the proportion of patients whose tumors have shrunk to a certain level and maintained for a certain period of time, including cases of CR and PR. The solid tumor remission assessment standard (RECIST 1.1) was used to evaluate the objective tumor remission.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253873
|Contact: Hui Wu, email@example.com|
|Henan Cancer Hospital||Recruiting|
|Zhengzhou, Henan, China, 450008|
|Contact: hui Wu 13503716710 firstname.lastname@example.org|
|Principal Investigator:||Hui Wu, archiater||Henan Cancer Hospital|