An One Arm, Open and Prospective Studyof Apatinib for the Treatment of Recurrent or Recurrent High-grade Glioma

West China Hospital0 sites30 target enrollmentJanuary 4, 2018

ConditionsGlioma

InterventionsApatinib

DrugsApatinib

Overview

Phase: Phase 2
Intervention: Apatinib
Conditions: Glioma
Sponsor: West China Hospital
Enrollment: 30
Primary Endpoint: Progress-free Survival(PFS)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effectiveness and safety of Apatinib for patients with Recurrent or Recurrent High-grade Glioma.

Registry

clinicaltrials.gov

Start Date

January 4, 2018

End Date

August 1, 2020

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

West China Hospital

Responsible Party

Principal Investigator

Li ping

M.D.

West China Hospital

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old, male or female;
•The histologically confirmed first-line after the surgical resection of the WHOIII / IV glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of WHOIII / IV glioma;
•ECOG score: 0-2 points;
•The main organs function properly, that is, meet the following criteria:(1) blood test:a. HGB≥90 g / L;b. ANC ≧ 1.5 × 109 / L;c. PLT ≥80 × 109 / L;(2) biochemical examination:a. ALB≥30g / L;b. ALT and AST \<2\*ULN;c. TBIL≤1.5\*ULN; d. Plasma Cr≤1.5 \*ULN;
•No history of mental illness in patients;
•Thyroid function is normal;
•Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria

•Pregnant or lactating women;
•Hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure\> 150 mmHg and diastolic blood pressure\> 100 mmHg); those with grade I or greater myocardial ischemia or myocardial infarction, arrhythmia (including QT Period ≥ 440 ms) and grade I cardiac insufficiency, grading reference NCI-CTC AE 3.0;
•Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
•Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
•Have mental illness, or history of substance abuse;
•Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; allowing the use of small doses of prophylaxis for prophylaxis, provided that the prothrombin time has an International Normalized Ratio (INR) ≤1.5 Farin (1 mg orally, once daily), low dose heparin (6,000 to 12,000 U daily for adults), or low dose aspirin (80 to 100 mg daily);
•Researchers think it is not suitable for inclusion. All patients underwent CT or MRI of the head one week prior to the start of the protocol, with intracranial hemorrhage.

Arms & Interventions

apatinib

apatinib 500 mg orally daily until the untolerabale toxicities、desease progress or death

Intervention: Apatinib

Outcomes

Primary Outcomes

Progress-free Survival(PFS)

Time Frame: 24month

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Overall Survival(OS)

Time Frame: 24 month

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.