Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glioblastoma Response Prediction to Apatinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04814329
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Junping Zhang, Beijing Sanbo Brain Hospital

Brief Summary:
Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. Some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients. However, a subset of patients progressed in 2 months. There is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy. In this study, whole genome sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.

Condition or disease Intervention/treatment
Glioblastoma Other: genetic characteristic

Layout table for study information
Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Study on Predicting Response of Recurrent Glioblastoma to Apatinib
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
effective group
After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months.
Other: genetic characteristic
the underlying genetic characteristics that prodicting response

stable group
After treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months.
Other: genetic characteristic
the underlying genetic characteristics that prodicting response

Early progressed group
After treatment, tumor got progressed and the progression-free survival time was no more than 1 month.
Other: genetic characteristic
the underlying genetic characteristics that prodicting response




Primary Outcome Measures :
  1. genetic outcome [ Time Frame: up to 2 years ]
    response prodicting biomarker



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University
Criteria

Inclusion Criteria:

  1. Age 18-70 years old
  2. recurrent glioblastoma
  3. received apatinib plus temozolomide treatment,response and survival data were available
  4. tumor tissues were acquired

Exclusion Criteria:

-


Information from the National Library of Medicine

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): NCT04814329


Contacts
Layout table for location contacts
Contact: Jun-ping Zhang 86-010-62856783 doczhjp@hotmail.com

Locations
Layout table for location information
China
Capital Medical University Sanbo Brain Hospital Recruiting
Beijing, China
Contact: Junping Zhang    86-010-62856783    doczhjp@hotmail.com   
Sponsors and Collaborators
Beijing Sanbo Brain Hospital
Layout table for additonal information
Responsible Party: Junping Zhang, Chief physician, Beijing Sanbo Brain Hospital
ClinicalTrials.gov Identifier: NCT04814329    
Other Study ID Numbers: 2021ZZLX03
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Junping Zhang, Beijing Sanbo Brain Hospital:
Vascular Endothelial Growth Factor Receptor 2
Biomarkers
glioblastoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue