Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

October 9, 2020 updated by: Zhongping Chen, Sun Yat-sen University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Cancer center of Sun Yat sen University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ke Chao kechao@sysucc.org.cn, PHD
        • Principal Investigator:
          • Chen Zhongping chenzhp@sysucc.org.cn, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
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 Frame: 3 years
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 Frame: 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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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