Glioma
Conditions
Interventions
Case series:Radiotherapy + Apatinib + Temozolamide +SHR1210
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years old; 2. patients diagnosed as refractory grade III to IV glioma according to the diagnostic criteria of the world health organization; 3. inclusion of patient regulations: (1) Patients with high microsatellite instability (MSI -- H)/ mismatch repair defect (dMMR) positive/pd-l1 positive (> 5%); (2) high expression of EGF pathway; 4. have at least one measurable lesion according to the evaluation criteria of solid tumor efficacy; 5. ECOG: 0 ~ 1; 6. the expected survival time is more than 12 weeks; 7. the functions of important organs meet the following requirements (no blood components and cytokines are allowed to be used 2 weeks before the treatment of the study) : (1) Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L; (2) Platelets greater than or equal to 100 x 10^9/L; (3) Hemoglobin greater than or equal to 9g/dL; (4) Serum albumin greater than or equal to 2.8g/dL; (5) bilirubin is less than or equal to 1.5 times ULN, ALT and AST are less than or equal to 2.5 times UILN;If liver metastasis exists, ALT and AST are less than or equal to 5 ULN. (6) Creatinine clearance is more than 50mL/min (Cockcroft-Gault, see annex ii); (7) Normal thyroid function. 8. fertile female subjects shall conduct a urine or serum pregnancy test within 72 hours prior to the first study drug administration, which shall prove to be negative, and shall be willing to use effective contraceptive methods during the study period and within 3 months after the last shr-1210 administration.For male subjects whose partner is a woman of child-bearing age, effective contraceptive methods should be adopted during the test period and within 3 months after the last shr-1210 administration; 9. subjects voluntarily participate in this study.The informed consent was signed with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. The main portal vein was completely embolized with less collateral vessel formation; 2. Extrahepatic diffusion, including invasion of the inferior vena cava; 3. Patients preparing for liver transplantation; 4. Patients with diffuse liver cancer; 5. The AFP 1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant treatment;The coagulation function was seriously decreased and could not be corrected. 7. Received molecular targeted drug therapy, radiotherapy and chemotherapy except apatinib before enrollment; 8. Patients with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmia (including QTc interval greater than 450 ms in males and 470 ms in females); 9. Patients with serious abnormal pulmonary function; 10. Tumor volume exceeded 70% of liver volume; 11. Patients allergic to any of apatinib's components; 12. Patients with active bleeding; 13. Patients with peptic ulcer, intestinal perforation or intestinal obstruction; 14. Patients within 30 days after major surgery; 15. Patients with hypertension still have poor blood pressure control after antihypertensive drug treatment (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg); 16. The urine routine showed that the urine protein was greater than ++ or confirmed the quantitative > 1.0g of urine protein at 24 hours; 17. Pregnant or breast-feeding female patients; 18. Has a history of mental illness or psychotropic substance abuse; 19. Patients and/or family members do not agree to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS; | — |
Countries
China
Contacts
Public ContactWang Feng
West China Hospital, Sichuan University
Outcome results
None listed