Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• 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

• China
  • 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

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Biological: PD-1; Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG; Other Names: apatinib
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.	Biological: PD-1; Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG; Other Names: apatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

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