recurrent glioblastoma
Conditions
Interventions
Experimental group:lercanidipine + bevacizumab
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent (ICF); 2. Aged from 18 to 70 years, no gender limit; 3. Recurrent glioblastoma confirmed by imaging or pathological findings; 4. Postoperative radiotherapy was received, and the time interval from the last radiotherapy was >=3 months; 5. No more than one chemotherapy regimen was received after surgery, and the interval from the last chemotherapy was >=4 weeks; 6. The time interval from the last operation >=2 weeks; 7. ECOG score of physical condition was 0-1, and did not deteriorate within the first 2 weeks of enrollment. Expected survival is not less than 12 weeks; 8. It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the protocol requirements; 9. KPS score >=60, EORTC 0-1; 10. Normal functions of major organs, no serious abnormalities of blood, heart, lung, liver, kidney function and immune deficiency; 11. Normal coagulation function, no active bleeding and thrombosis diseases; 12. The subject must undergo a laboratory examination within 14 days of the first dose, and the laboratory examination indicators shall meet the following criteria: (1) Platelet >=100x10^9/L; (2) Absolute count of neutrophils (ANC) >=1.5x10^9/L; (3) Absolute leukocyte count (WBC) >=3.5x10^9/L and =90 g/L (no blood transfusion or use of erythropoietin within 4 weeks); (5) Total bilirubin =30g/L; (7) Creatinine =50 mL/min (calculated by Cockcroft-Gault formula); (8) Subjects who were not taking anticoagulants, or who had been taking anticoagulants, had stopped taking drugs for 28 days before enrollment, and had an international normalized ratio (INR) <=1.5 and an activated partial thromboplastin time (APTT) <=1.5 ULN; 13. Female subjects of childbearing age had a negative serum pregnancy test 3 days before receiving the first dose; Female subjects of childbearing age and male subjects with partners of childbearing age must agree to use effective contraception during the study period and for 180 days after receiving the final dose; 14. Able to swallow and take oral medications.
Exclusion criteria
Exclusion criteria: 1. Patients with severe bleeding or recent hemoptysis (>=1/2 teaspoon blood); 2. Uncontrolled hypertension and hypertensive crisis patients; 3. Patients who were scheduled to undergo major traumatic surgery within 4 weeks prior to administration or during the study period, or whose wounds were not fully healed within 4 weeks prior to administration; 4. Patients with past digestive tract perforation or digestive tract fistula, or perforation or fistula after previous use of bevacizumab; 5. Lactating patients; 6. Patients who cannot tolerate chemotherapy; 7. In addition to intracranial tumors, there are other malignant tumors; 8. Schizophrenia with previous clinical diagnosis; 9. Patients who could not perform MRI examination; 10. Previous cancer treatment-related toxicity did not return to baseline levels; 11. According to the investigator's judgment, the patient had other factors that might affect the study results or lead to the forced termination of the study, such as alcoholism, drug abuse, or with other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, and family or social factors that would affect the safety of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival at 6 months;Disease control rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactPu Jun
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed