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Single arm, open, prospective study low dose of Apatinib in the treatment of primary and recurrent high grade gliomas

Single arm, open, prospective study low dose of Apatinib in the treatment of primary and recurrent high grade gliomas

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015764
Enrollment
Unknown
Registered
2018-04-19
Start date
2018-04-23
Completion date
Unknown
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary and recurrent high grade gliomas

Interventions

Case series:apatinib + Temozolomide + radiotherapy

Sponsors

Gansu Province Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18 years of age or older; 2. a newly diagnosed grade WHOIII/IV glioma after surgery, or recurrent grade WHOIII/IV glioma after surgery and / or radiotherapy and chemotherapy, was confirmed by histopathology; 3. ECOG score: 0-2 points; 4. The main organ function:HGB=90 g/L; ANC=1.5*10^9/L; PLT=80*10^9/L; Biochemical examination: ALB=30g / L, ALT and AST <2ULN, TBIL =1.5ULN; serum Cr=1.5ULN; 5. coagulation function: INR=1.5ULN, APTT=1.5ULNULN; 6. The subjects voluntarily joined the study, informed consent, good compliance, with the follow-up.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating; 2. After suffering from high blood pressure and antihypertensive medications can not fall within the normal range (systolic blood pressure> 150 mmHg, diastolic blood pressure> 100 mmHg); above the level of suffering I coronary heart disease or arrhythmia (including QT interval of =440 ms) and Class I cardiac insufficiency (according to NCI-CTC AE 3.0); Patients who take antiarrhythmic drugs or have underlying heart disease, bradycardia, and electrolyte disorders;The occurrence of arterial thrombosis, cerebrovascular accident; 3. obvious factors of oral drug absorption, such as inability to swallow, nausea, emesis, chronic diarrhea and intestinal obstruction; Patients with clear gastrointestinal bleeding concerns, including the following situations: local active ulcerative lesions, and defecate occult blood (++); the history of hemorrhage in the digestive tract within 6 months; 4. Patients treated with thrombolytic therapy, anticoagulant or vitamin K antagonist such as warfarin, heparin or its analogues; In the standardization of the prothrombin time ratio (INR) under the premise of 1.5 or less, allowing to use low-dose warfarin (1 mg orally, once per day), small dose of heparin (adult daily dose is 06000 ~ 12000 U) or low-dose aspirin (80 mg daily dose in to 100 mg); 5. Severe liver and renal insufficiency (cet-4);3/4 levels of transaminase and total bilirubin increased; 6. Within 30 days after the operation or the wound has not healed; 7. history of mental illness or psychotropic substance abuse; 8. Surgical history of other diseases in the skull; 9. patients who physicians suggest not be included; 10. All patients should have a head MRI scan a week before the program begins, such as intracranial hemorrhage.

Design outcomes

Primary

MeasureTime frame
SPFS;PFS;OS;

Secondary

MeasureTime frame
ORR;QoL;Changes in hormone dosage and the dosage of intracranial edema dehydrated drugs;

Countries

China

Contacts

Public ContactGao Liying

Gansu Province Cancer Hospital

lygaolanzhou@163.com+86 13993162152

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026