Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Sun Yat-sen University

Status and phase: Unknown; Phase 2

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

Treatments: Biological: PD-1

Study type: Interventional

Funder types: Other

Identifiers

NCT04588987

MA-GBM-II-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Neoadjuvant group

Experimental group

Description:

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

Treatment:

Biological: PD-1

Adjuvant group

Experimental group

Description:

Before surgery, patients no need to treat with PD-1 and apatinib. Sequential therapy with PD-1 and apatinib when patients accepted surgery.

Treatment:

Biological: PD-1