recurrent glioblastoma
Conditions
Interventions
combined therapy group:Toripalimab and Anlotinib
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, no gender preference. 2. Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma who once received surgery treatment and postoperative standard chemoradiotherapy (TMZ program). Radiographic or surgery evidence of tumor progression or recurrence. 3. Patients did not receive corticosteroid within 7 days before scan or corticosteroid dose must be stable or decreasing for at least 7 days prior to the scan. 4. KPS score should be at least 70%. Drugs can be given by mouth. 5. Estimated survival >= 3 months 6. The bone marrow, liver and kidney function must meets the following requirements within 21 days before scan. a) ANC >= 1.5 x 10^9/L, PLT >= 100 x 10^9/L, HGB >= 9.0 g/L(Blood transfusion or other ways is acceptable) b) creatinine clearance rate >= 30ml/min (Cockcroft-Gault formula); c) T-BIL <= 1.5 times upper limit of normal value (ULN); ALT and AST <= 3.0 times ULN; T-BIL <= 3.0 times ULN is acceptable if the patients with Gilbert Syndrome. 7. ECG didnt shows acute myocardial ischemia within 21 days before scan. 8. Women of child-bearing age were non-lactation and shall undergo a pregnancy test (serum or urine) with negative results within 7 days prior to enrollment. Women or their partner already had sterilization surgery or postmenopausal for at least 2 years were also acceptable. Women of child-bearing age must agree to use a medically approved contraceptive method during the treatment period and for at least 3 months following the last dose of study drug. Men must agree to use a reliable method of contraceptive during the study and for at least 3 months following the last dose of study drug. (use of the intrauterine devicecondom with spermicideany form of birth control pills or Abstinence). 9. Patients volunteered to participate in the study and signed an informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients who have received bevacizumab, radioiodine therapy, short cycle radiotherapy within 1 month or plan to take radiotherapy during the study. 2. Contraindicated for contrast enhancement MRI examination. 3. Patients who have NYHA class III or IV cardiac failure, unstable angina, acute myocardial ischemia and perpetual arrhythmia within 6 months before scan. 4. Patients who have severe trauma or infectious diseases that affect current therapy within 4 weeks. 5. Patients who have chronicity toxicity response >= grade 3(NCI-CTCAE 5.0). 6. Patients who have had major operations within 4 weeks, except surgery for glioma. Patients who had bone marrow biopsy, open biopsy, intracranial lesion biopsy within 7 days before scan or patients with other high hemorrhagic risk. 7. Positive serology for HIV infection, HBsAg and HBV-DNA, anti-HCV and HCV-RNA. 8. Patients with other malignant tumors that has not been effectively controlled within 5 years.(except cervical carcinoma in situ, cutaneous squamous cell carcinoma and localized basal cell carcinomas). 9. Patients who need continue hematopoietic growth factor therapy to maintain ANC >= 1.5 x 10^9/L.(including granulocyte colony-stimulating factor, macrophage colony stimulating factor and Interleukin– 11). Patients who need platelet transfusion to maintain PLT >= 75 x 10^9/L. 10. Women who are pregnant, breast-feeding or plan to get pregnant during the study. 11. Patients who are included in other clinical trials within 30 days. 12. Other conditions considered by the researchers to be inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate;Karnofsky Performance Status;Quality of Life score (EORTC QLQ-C30 and EORTC QLQ-BN20); | — |
Countries
China
Contacts
Public ContactLiang Wang
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed