- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04588987
Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma
October 9, 2020 updated by: Zhongping Chen, Sun Yat-sen University
A Study to Evaluate the Safety and Efficiency of Using the Neoadjuvant Therapy With Carilizumab and Apatinib in Patients With Recurrent High-Grade Glioma :A Prospective, Randomized Study
GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor.
The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chen Zhong ping, PHD
- Phone Number: 020-8734009
- Email: chenzhp@sysucc.org.cn
Study Contact Backup
- Name: Ke Chao, PHD
- Email: kechao@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Cancer center of Sun Yat sen University
-
Contact:
- Ke Chao, PHD
- Email: kechao@sysucc.org.cn
-
Contact:
- Ju xue, PHD
- Email: yangqy@sysucc.org.cn
-
Sub-Investigator:
- Ke Chao kechao@sysucc.org.cn, PHD
-
Principal Investigator:
- Chen Zhongping chenzhp@sysucc.org.cn, PHD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent.
- Age 18-70 years old, both male and female.
- After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma.
- Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator.
- KPS score ≥60;
- Life expectancy >12 weeks.
Adequate organ function defined by:
- HGB≥110g/L;
- WBC≥3.0×109/L;NEUT≥1.5×109/L;
- PLT ≥75×109/L;
- BIL≤1.5ULN;
- ALT and AST≤2.0×ULN;
- creatinine < 1.5 x ULN or estimated creatinine clearance≥50ml/min(using the Cockcroft-Gault formula)
Exclusion Criteria:
- Presence of extracranial disease.
- Previous treatment with a PD-1, PDL-1 or CTLA-4,VEGFR targeted therapy.
- Pregnant or breastfeeding patients.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
- Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
- History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
- Known drug or alcohol abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neoadjuvant group
Patients need to treat with PD-1 and apatinib before surgery.
Sequential therapy with PD-1 and apatinib when patients accepted surgery.
|
Neoadjuvant PD-1 and Apatinib for rHGG.
Adjuvant PD-1 and Apatinib for rHGG
Other Names:
|
Experimental: Adjuvant group
Before surgery, patients no need to treat with PD-1 and apatinib.
Sequential therapy with PD-1 and apatinib when patients accepted surgery.
|
Neoadjuvant PD-1 and Apatinib for rHGG.
Adjuvant PD-1 and Apatinib for rHGG
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 3 years
|
Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival(PFS)
Time Frame: 18 months
|
Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
September 6, 2020
First Submitted That Met QC Criteria
October 9, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
October 19, 2020
Last Update Submitted That Met QC Criteria
October 9, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Recurrence
- Glioma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- MA-GBM-II-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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