Glioma
Conditions
Interventions
Intervention group:Teriprizumab neoadjuvant immunotherapy + temozolomide capsules combined with IMRT concurrent chemotherapy + postoperative adjuvant radiotherapy + oral temozolomide capsules adjuvant
Control group:Temozolomide capsules combined with IMRT concurrent chemotherapy + postoperative adjuvant radiotherapy + oral temozolomide capsules adjuvant chemotherapy one month after the end of radio
Sponsors
The Affiliated Hospital of Guizhou Medical University/The Affiliated Cancer Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Glioma patients with WHO grade III or IV confirmed by pathology; 2. All patients were residual after surgical treatment; 3. Male or female, aged > 18 and = 60 points; 5. Functional brain MRI showed residual tumor; 6. There are measurable or evaluable lesions; 7. Sufficient liver and kidney function: total bilirubin = 80 ml / min; 8. Sufficient blood function: neutrophil count (ANC) >= 2 x 10^9 / L, platelet count >= 100 x 10^9 / L and hemoglobin >= 9 g / dl; 9. Karnofsky score >= 70; 10. Ptients and their family members should sign informed consent and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received anti-tumor treatment, including chemotherapy and radiotherapy; 2. Patients with malignant tumors other than gliomas; 3. Woman is pregnant or lactating; 4. Receive the experimental treatment of other clinical studies (in the treatment period of clinical studies); 5. Known allergy to chemotherapeutic drugs that may be used; 6. With severe uncontrollable infection or medical diseases; 7. Major organ dysfunction, such as decompensated heart, lung, kidney and liver failure, could not tolerate radiotherapy and chemotherapy; 8. Laboratory examination: total bilirubin > upper limit of normal (ULN); AST and / or ALT > 1.5 times ULN with alkaline phosphatase > 2.5 times ULN; 9. There are factors affecting the administration, distribution, metabolism and excretion, such as mental disorders, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc; 10. Long term use of immunosuppressants after organ transplantation; 11. Patients with history of other malignant tumors before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate;Quality of life; | — |
Countries
China
Contacts
Public ContactLuo Xiuling
The Affiliated Hospital of Guizhou Medical University/The Affiliated Cancer Hospital of Guizhou Medical University
Outcome results
None listed