Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Neoadjuvant Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588987
• Other study ID #: MA-GBM-II-001
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2020
• Est. completion date: May 2024

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: Chen Zhong ping, PHD
• Phone: 020-8734009
• Email: chenzhp[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Written informed consent.

2. Age 18-70 years old, both male and female.

3. After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma.

4. 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.

5. KPS score =60;

6. Life expectancy >12 weeks.

7. Adequate organ function defined by:

1. HGB=110g/L;

2. WBC=3.0×109/L;NEUT=1.5×109/L;

3. PLT =75×109/L;

1. BIL=1.5ULN;

2. ALT and AST=2.0×ULN;

3. creatinine < 1.5 x ULN or estimated creatinine clearance=50ml/min(using the Cockcroft-Gault formula)

Exclusion Criteria:

1. Presence of extracranial disease.

2. Previous treatment with a PD-1, PDL-1 or CTLA-4,VEGFR targeted therapy.

3. Pregnant or breastfeeding patients.

4. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.

5. Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.

6. History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.

7. Known drug or alcohol abuse.

Related Conditions & MeSH terms

• Apatinib
• Carilizumab
• Glioma
• Neoadjuvant Therapy
• Recurrent High-Grade Glioma

Intervention

Biological:
• PD-1
Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG

Locations

Country	Name	City	State
China	Cancer center of Sun Yat sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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	Progression-free survival(PFS)	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