Meningioma
Conditions
Interventions
Experimental group:Sintilimab Combined with Lenvatinib
Sponsors
General Hospital of the Northern Theater Command of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before the implementation of any trial-related procedures; 2. Male or female, =18 years old; 3. ECOG PS score 0-2; 4. Pathologically confirmed grade 2-3 meningiomas; 5. Tumor recurrence and metastasis or residual lesions after previous meningioma surgery (prior radiotherapy may have been received, but disease progression must be identified, and at least 24 weeks after the end of the last radiotherapy); 6. There was at least 1 measurable intracranial lesion; 7. It had sufficient organ and bone marrow function, and the laboratory test values before enrollment met the following requirements: 1) Blood routine: absolute neutrophil count (ANC) =1.5×109/L; platelet count (PLT) =100×109/L; hemoglobin content (HGB) =9.0 g/dL; 2) Liver function: serum total bilirubin (TBIL) =1.5× upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) =2.5×ULN; serum albumin =28 g/L; 3) Renal function: serum creatinine (Cr) = 1.5×ULN or creatinine clearance (CCr) = 50mL/min (Cockcroft-Gault formula); urine routine results showed urinary protein<2+; for patients with urine protein =2+ at baseline, 24-hour urine collection and 24-hour protein quantification should be performed<1g; 4) Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 times ULN; 8. For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days before receiving the first study drug administration (day 1 of the cycle ). If the results of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Women who are not in their reproductive age were defined as those who have been at least one year after menopause or have undergone surgical sterilization or hysterectomy. 9. In cases where there is a potential risk of conception, all subjects (both male and female) must utilize a contraceptive method with an annual failure rate of less than 1% throughout the entire duration of treatment, up to 120 days following the last administration of the study drug (or 180 days after the final administration of the study drug).
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignancies within 5 years prior to initial administration, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ; 2. Esophageal or fundus variceal bleeding events caused by portal hypertension have occurred in the past 6 months. Known endoscopic presence of severe (G3) varicose veins within 3 months prior to first dosing; Patients with evidence of portal hypertension (including splenomegaly on imaging) who are at high risk of bleeding as assessed by the investigator; 3. Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion treatment, surgery or local treatment, continuous medication; 4. Previous arterial or venous thromboembolism events, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other history of severe thromboembolism within the past 6 months, except those with implantable intravenous infusion ports or catheter-borne thrombosis or superficial venous thrombosis, and thromboembolism stabilization after routine anticoagulant therapy, Allow the prophylactic use of low-dose, low-molecular heparin (e.g., enoxaparin 40 mg/ day); 5. Use aspirin (> 325 mg/ day) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, for 10 consecutive days within 2 weeks before the first administration; 6. Uncontrolled hypertension, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 7. Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmia. A QTc > 500ms adjusted for congenital long QT syndrome history or screening (calculated using the Fridericia method); 8. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy; 9. A previous history of gastrointestinal perforation and/or fistula within the last 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterectomy (partial colectomy or extensive enterectomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 10. Screening patients who received radiation therapy for meningioma within the first 24 weeks of enrollment; 11. Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases; 12. People with active tuberculosis (TB) who are receiving anti-TB therapy or who have received anti-TB therapy within 1 year prior to the first dose; 13. Persons infected with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA > 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA > 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were positive simultaneously; 14. Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection; 15. A serious infection that is active or poorly controlled clinically. Severe infection in the 4 weeks prior to initial dosing, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; 16. An active autoimmune disease requiring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFS Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;objective response rate;disease control rate;Duration of relief;safety; | — |
Countries
China
Contacts
Public ContactSizhe Feng
General Hospital of the Northern Theater Command of the Chinese People's Liberation Army
Outcome results
None listed