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

Phase 2

• Conditions: Glioma
• Interventions: Drug: Apatinib

• Registration Number: NCT03390062
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-26
• Last Update Submitted: 2017-12-26
• Study Start: 2018-01-04
• Study First Posted: 2018-01-04
• Last Update Posted: 2018-01-04
• Primary Completion: 2019-12-20
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apatinib	Apatinib	apatinib 500 mg orally daily until the untolerabale toxicities、desease progress or death

Primary Outcome Measures

Name	Time	Method
Progress-free Survival(PFS)	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)	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.

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C30	24month	The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients.
Objective Response Rate(ORR)	6month	Proportion of patients with reduction in tumor burden of a predefined amount