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Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Primary Purpose

Neoadjuvant Therapy, Carilizumab, Apatinib

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PD-1

About this trial

This is an interventional treatment trial for Neoadjuvant Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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:

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.

Sites / Locations

Cancer center of Sun Yat sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Neoadjuvant group

Adjuvant group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04588987

First Posted

September 6, 2020

Last Updated

October 9, 2020

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04588987

Brief Title

Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Recruiting

Study Start Date

October 2020 (Anticipated)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant group

Arm Type

Experimental

Arm Description

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

Arm Title

Adjuvant group

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

PD-1

Other Intervention Name(s)

apatinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Progression-free survival(PFS)

Description

Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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； 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） Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Zhong ping, PHD

Phone

020-8734009

chenzhp@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Ke Chao, PHD

kechao@sysucc.org.cn

Facility Information:

Facility Name

Cancer center of Sun Yat sen University

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ke Chao, PHD

kechao@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Ju xue, PHD

yangqy@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Ke Chao kechao@sysucc.org.cn, PHD

First Name & Middle Initial & Last Name & Degree

Chen Zhongping chenzhp@sysucc.org.cn, PHD

12. IPD Sharing Statement

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Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

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