Clinical trial NCT03390062: A Study of Apatinib in Recurrent or Recurrent High-grade Glioma
Official title: An One Arm, Open and Prospective Studyof Apatinib for the Treatment of Recurrent or Recurrent High-grade Glioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioma
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2018-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: 24 month
measure: Progress-free Survival(PFS)
timeFrame: 24month
Secondary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: 6month
measure: EORTC QLQ-C30
timeFrame: 24month
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: qing Mao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: