Last updated: March 26, 2021
Sponsor: First People's Hospital of Hangzhou
Overall Status: Active - Recruiting
Phase
2
Condition
Brain Cancer
Brain Tumor
Astrocytoma
Treatment
N/AClinical Study ID
NCT04822805
H2CH2020M504
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years old (calculated on the day of signing the informed consent), regardlessof gender.
- Karnofsky score (KPS score) ≥60.
- According to Rano criteria, there are evaluable intracranial lesions, and recurrenthigh-grade gliomas have been confirmed.
- Patients have undergone surgery and relapsed after receiving standard radiotherapy andchemotherapy;
- The toxicity has returned to ≤1 grade If have received chemotherapy;
- Expected survival ≥ 3 months;
- The patient has no major organ dysfunction. Specific laboratory indicators arerequired: white blood cells ≥3.0×109/L, platelets ≥75×109/L, hemoglobin ≥10g/dl, andserum bilirubin not greater than 1.5 times the maximum normal value; ALT and AST arenot more than 2 times the maximum normal value; blood creatinine ≤ 1.5 mg/dl.
- Men and women of gestational age must agree to take adequate contraceptive measuresthroughout the study period.
- The patient voluntarily joined the study and signed a written informed consent.
Exclusion
Exclusion Criteria:
- Those who have multiple factors that affect oral medications (such as inability toswallow, chronic diarrhea, intestinal obstruction, etc.);
- Patients with any severe and/or uncontrollable disease, including:
- Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg,diastolic blood pressure ≥100 mmHg); 2) Patients with myocardial ischemia or myocardialinfarction above grade I, arrhythmia (including QTC ≥480ms), and grade ≥2 congestive heartfailure (New York Heart Association (NYHA) classification); 3) Active or uncontrolledserious infection (≥CTC AE Grade 2 infection); 4) Liver cirrhosis, decompensated liverdisease, active hepatitis or chronic hepatitis require antiviral treatment; 5) Renalfailure requires hemodialysis or peritoneal dialysis; 6) Have a history ofimmunodeficiency, including HIV positive or other acquired or congenital immunodeficiencydiseases, or a history of organ transplantation; 7) Diabetes is poorly controlled (fastingblood glucose (FBG)> 10mmol/L); 8) Urine routines suggest that urine protein is ≥++, andthe 24-hour urine protein quantification is more than 1.0 g; 9) Patients who have seizuresand need treatment; 3. Received major surgical treatment, open biopsy or obvious traumaticinjury within 28 days before enrollment; 4. Patients whose imaging shows that the tumor hasinvaded important blood vessels or the researcher judges that the tumor is likely to invadeimportant blood vessels causing fatal hemorrhage during the follow-up study; 5. Regardlessof the severity, patients with any signs of bleeding or medical history; within 4 weeksbefore enrollment, patients with any bleeding or bleeding event ≥ CTCAE level 3, unhealedwounds, ulcers or fractures; 6. Those who have had arterial/venous thrombosis within 6months, such as cerebrovascular accidents (including temporary ischemic attacks), deep veinthrombosis and pulmonary embolism; 7. Those who have a history of psychotropic drug abuseand cannot be quit or have mental disorders; 8. Participated in clinical research of otheranti-tumor drugs within four weeks; 9. Have received the treatment of small moleculeanti-angiogenesis targeted drugs (such as regorafenib, perzopanib, apatinib, etc.); 10.Those considered by the researcher to be unsuitable for inclusion。
Study Design
Total Participants: 27
Study Start date:
April 13, 2020
Estimated Completion Date:
March 30, 2023
Study Description
Connect with a study center
Hangzhou Cancer Hospital
Hangzhou, 310000
ChinaActive - Recruiting

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