Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma
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ClinicalTrials.gov Identifier: NCT03567135 |
Recruitment Status :
Recruiting
First Posted : June 25, 2018
Last Update Posted : March 3, 2020
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Condition or disease | Intervention/treatment |
---|---|
Glioblastoma | Drug: Apatinib Drug: Temozolomide(TMZ) |
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma. |
Actual Study Start Date : | October 1, 2017 |
Actual Primary Completion Date : | April 1, 2019 |
Estimated Study Completion Date : | October 1, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Experimental 1
concurrent chemoradiotherapy(Temozolomide+apatinib) maintenance therapy(Temozolomide)
|
Drug: Apatinib
These drugs are planned to inhibit the proliferation and metastasis of tumors.
Other Name: Temozolomide(TMZ) Drug: Temozolomide(TMZ) Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced. |
control
concurrent chemoradiotherapy(Temozolomide) maintenance therapy(Temozolomide)
|
Drug: Temozolomide(TMZ)
Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced. |
Experimental 2
concurrent chemoradiotherapy(Temozolomide+apatinib) maintenance therapy(Temozolomide+apatinib)
|
Drug: Apatinib
These drugs are planned to inhibit the proliferation and metastasis of tumors.
Other Name: Temozolomide(TMZ) Drug: Temozolomide(TMZ) Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced. |
- Progression-Free-Survival(PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. ]in this Survival Duration neither Progression nor death occurs in the subjects.
- Assessment of brain edema [ Time Frame: From date of randomization until the date of end of the trial, assessed up to 36 months ]The average score of edema grading in patients before and after treatment was calculated separately.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From date of randomization until the date of end of the trial, assessed up to 36 months ]To observe any adverse events that occurred during the clinical study.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Search Criteria:
- Subjects received anti-angiogenesis drugs simultaneous accompanied with radio-and chemotherapy in Fuzhou Zongyuan since October, 2017;
- Age: 18-70 years;
- The first surgical pathology was diagnosed as glioblastoma, WHO grade III or IV;
- Patients who have previously received no more than one surgical treatment;
- ECOG performance status: 0-2;
- Survival expectation≥3 months.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567135
Contact: Wenmin Ying, Bachelor | 15080015210 | 18352770@qq.com |
China, Fujian | |
Fuzhou General Hospital | Recruiting |
Fuzhou, Fujian, China, 350025 | |
Contact: Wenmin Ying, Bachelor 15080015210 18352770@qq.com |
Responsible Party: | Fuzhou General Hospital |
ClinicalTrials.gov Identifier: | NCT03567135 |
Other Study ID Numbers: |
20180524 |
First Posted: | June 25, 2018 Key Record Dates |
Last Update Posted: | March 3, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Temozolomide Apatinib Radiotherapy |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Temozolomide Apatinib Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors |