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A Study of Apatinib in Recurrent or Recurrent High-grade Glioma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Study of Apatinib in Recurrent or Recurrent High-grade Glioma

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

NCT03390062•West China Hospital

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Age ≥ 18 years old, male or female;
•2\. 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;
•3\. ECOG score: 0-2 points;
•4\. 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;
•5\. No history of mental illness in patients;
•6\. Thyroid function is normal;
•7\. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria

•1\. Pregnant or lactating women;
•2\. 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;
•3\. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
•4\. Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
•5\. Have mental illness, or history of substance abuse;
•6\. 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);
•7\. 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.

Key Dates

Start Date

January 4, 2018

Primary Completion Date

December 20, 2019

Completion Date

August 1, 2020

Last Updated

January 4, 2018

Enrollment

ESTIMATED participants

Conditions

Glioma

Interventions

Apatinib

DRUG

Contacts

ping Li, M.D.

CONTACT

08618980602780 lipinglunwen@163.com

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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: January 4, 2018Data 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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A Study of Apatinib in Recurrent or Recurrent High-grade Glioma

Inclusion Criteria

Exclusion Criteria

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