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Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma | Clinical Trials | Clareo Health

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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

NCT04588987•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

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；
+4 more criteria

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.

Locations (1)

Cancer center of Sun Yat sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

October 1, 2020

Primary Completion Date

October 1, 2023

Completion Date

May 1, 2024

Last Updated

October 19, 2020

Enrollment

ESTIMATED participants

Conditions

Neoadjuvant TherapyCarilizumabApatinibRecurrent High-Grade Glioma

Interventions

PD-1

BIOLOGICAL

Contacts

Chen Zhong ping, PHD

CONTACT

020-8734009 chenzhp@sysucc.org.cn

Ke Chao, PHD

CONTACT

kechao@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Inclusion Criteria

Exclusion Criteria

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