Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Phase 2

• Conditions: Apatinib; Neoadjuvant Therapy; Recurrent High-Grade Glioma; Carilizumab
• Interventions: Biological: PD-1

• Registration Number: NCT04588987
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-06
• Status Verified: 2020-10
• Study Start: 2020-10
• Study First Submitted QC: 2020-10-09
• Last Update Submitted: 2020-10-09
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Primary Completion: 2023-10
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant group	PD-1	Before surgery, patients no need to treat with PD-1 and apatinib. Sequential therapy with PD-1 and apatinib when patients accepted surgery.
Neoadjuvant group	PD-1	Patients need to treat with PD-1 and apatinib before surgery. Sequential therapy with PD-1 and apatinib when patients accepted surgery.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	3 years	Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	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

Trial Locations

Locations (1)

Cancer center of Sun Yat sen University; 🇨🇳 Guangzhou, Guangdong, China