glioblastoma
Conditions
Interventions
experimental group:tumor treating fields /apatinib
Sponsors
West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: A. Subjects aged >= 18 years; B. Patients diagnosed as GBM by pathological examination after glioma resection (acceptable for patients with total resection, partial resection and biopsy) according to the World Health Organization (WHO) Central NERVOUS SYSTEM TUMOR classification criteria in 2016; C. Standard concurrent chemoradiotherapy [total RT dose of about 60 Gy, concurrent TMZ chemotherapy (75 mg/m2)] and adjuvant chemotherapy [150-200 mg/ (m2.d) of TMZ adjuvant chemotherapy, stopped for 23 days after 5 consecutive days, with a 28-day cycle, and 612 cycles planned to be completed]; D. Optune >= 18h to be worn daily; E. Karnofsky score of subjects >= 70; F. Expected survival time of subjects >= 3 months; G. Women of child-bearing age who are using effective contraceptives (an effective method of contraception is defined as having a failure rate of less than 1% per year if used consistently and correctly); H. Subjects starting adjuvant therapy at a steroid dose equivalent to dexamethasone <= 4mg/day; I. Subjects may receive MRI (including enhancement) examination; J. Subjects agree to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: A. Subjects received any other cytotoxic or biological antitumor therapy prior to enrollment; B. Subjects participate in another clinical trial within 3 months prior to enrollment; C. Subjects' bone marrow and liver and kidney function assessment 7 days before enrolment did not meet any of the following criteria: I) thrombocytopenia (platelet count 1.7 mg/dL or & gt;150 mu mol/L); D. Subject has an active implanted device (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, cardiac pacemaker, cardiac defibrillator, etc.). E. Subject has a subtentorial tumor; F. Increased intracranial pressure (clinically manifested as severe optic papillary edema, vomiting, nausea, or loss of consciousness); G. Subject is allergic to TTFields consumable (e.g. conductive hydrogel); H. The subject is a pregnant or lactating female; I. Subject's scalp wound healing is poor, head skin condition is poor, skull defect is large, intracranial metal sheet remains, or other conditions are not suitable for wearing electrodes as judged by the investigator; J. Recipients has a history of immunosuppressive diseases (such as history of HIV infection), history of other malignant tumors (not including the full treatment of cervical carcinoma in situ, squamous cell carcinoma of the skin and full control of the limitations of basal cell skin cancer), autoimmune disease history, history of active tuberculosis or researchers determine other organ systems of the serious diseases; K. Other circumstances that the Investigator considers inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 12 months (PFS12); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Health related quality of life (HRQOL); | — |
Countries
China
Contacts
Public ContactWang Feng
West China Hospital, Sichuan University
Outcome results
None listed