glioblastoma
Conditions
Interventions
experimental group:Semusine-Temozolomide
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients with newly diagnosed GBM were confirmed by pathological examination after brain surgery (complete resection or near subtotal resection) and according to the central nervous system tumor classification standard of 2016WHO; 2) Aged 18-70 years; 3) Karnofsky (KPS) score >= 70; 4) The expected survival time of the subjects is >= 3 months; 5) Fertile subjects must agree to use effective contraception during the study period; 6) Concurrent chemoradiotherapy begins within 6 weeks after brain surgery (<=6 weeks); 7) The subject agrees to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects received any other cytotoxic or biological anti-tumor therapy before enrollment; 2) The subject is also participating in another clinical trial or the subject is a pregnant or lactating woman; 3) The bone marrow, liver and kidney functions of the subjects before enrollment shall meet certain criteria, and any of the following conditions shall not be included: 1. Thrombocytopenia (platelet count 1.7mg/dL, or > 150 mol/L). 4) Confirmed increased intracranial pressure (clinically manifested as severe papilloma of the optic nerve, vomiting, nausea or loss of consciousness); 5) A known history of allergy to temozolomide and/or Smirstine; 6) Other researchers think it is not suitable to be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;disease control;quality of life;cognitive function; | — |
Countries
China
Contacts
Public ContactJunxin Wu
Fujian Cancer Hospital,
Outcome results
None listed