Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

NCT ID: NCT04588987

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2024-05-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant group

Patients need to treat with PD-1 and apatinib before surgery. Sequential therapy with PD-1 and apatinib when patients accepted surgery.

Group Type: EXPERIMENTAL

PD-1

Intervention Type: BIOLOGICAL

Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG

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.

Group Type: EXPERIMENTAL

PD-1

Intervention Type: BIOLOGICAL

Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG

Interventions

PD-1

Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG

Intervention Type: BIOLOGICAL

Other Intervention Names

apatinib

Eligibility Criteria

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；

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhongping Chen

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer center of Sun Yat sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Zhong ping, PHD

Role: CONTACT

chenzhp@sysucc.org.cn

020-8734009

Ke Chao, PHD

Role: CONTACT

kechao@sysucc.org.cn

Facility Contacts

Ke Chao, PHD

Role: primary

kechao@sysucc.org.cn

Ju xue, PHD

Role: backup

yangqy@sysucc.org.cn

Other Identifiers

MA-GBM-II-001

Identifier Type: -

Identifier Source: org_study_id