Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

NCT04588987 | Unknown Phase 2

• 1 other identifier: MA-GBM-II-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-free survival(PFS)

  18 months

Study Arms (2)

Neoadjuvant group

EXPERIMENTAL

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

Adjuvant group

EXPERIMENTAL

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

Interventions

PD-1 BIOLOGICAL

Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG

Also known as: apatinib

Adjuvant group; Neoadjuvant group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Age 18-70 years old, both male and female.
• After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma.
• 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.
• KPS score ≥60；
• Life expectancy \>12 weeks.
• Adequate organ function defined by:
• HGB≥110g/L；
• WBC≥3.0×109/L；NEUT≥1.5×109/L；
• PLT ≥75×109/L；
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• BIL≤1.5ULN；
• ALT and AST≤2.0×ULN；
• creatinine \< 1.5 x ULN or estimated creatinine clearance≥50ml/min（using the Cockcroft-Gault formula）

You may not qualify if:

• Presence of extracranial disease.
• Previous treatment with a PD-1, PDL-1 or CTLA-4，VEGFR targeted therapy.
• Pregnant or breastfeeding patients.
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
• Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
• History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
• Known drug or alcohol abuse.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of Sun Yat sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Chen Zhong ping, PHD

CONTACT

020-8734009; chenzhp@sysucc.org.cn

Ke Chao, PHD

CONTACT

kechao@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: May 1, 2024
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

CN (1)