Newly Diagnosed Papillary Craniopharyngioma with BRAF V600E Mutation
Conditions
Interventions
Experimental group:Prediction of BRAF V600E mutation in papillary craniopharyngioma: using a model to predict the pathological subtype of patients with novel craniopharyngioma
Drug treatment period: The patient received 150mg po bid of dalafenib and 2mg po qd of trametinib
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-74 years old; 2. Within 2 weeks before treatment, KPS score>=70; 3. Clinically confirmed as papillary craniopharyngioma; 4. Predict model suggests papillary craniopharyngioma with BRAF V600E mutation; 5. Tumor evaluated as measurable by the RANO (Response Assessment in Neuro Oncology) standard; 6. Expected survival time >= 6 months; 7. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Simultaneously suffering from other malignant tumors, excluding cured or stable malignant tumors; 2. Pregnant or lactating women; 3. Participated in clinical trials of other drugs within six months; 4. Hemoglobin1.5 × ULN (upper limit of normal value), blood alanine aminotransferase (ALT) or blood alanine aminotransferase (AST)>2.5 × ULN, endogenous creatinine clearance rate140 mmHg, diastolic blood pressure>90 mmHg); Individuals with a history of unstable angina pectoris; Newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction events occurring within 6 months prior to screening; Arrhythmias (including QTc: >= 450 ms) require long-term use of antiarrhythmic drugs and a New York Heart Association grade of >= II cardiac insufficiency; 7. Screening for incidents of arterial/venous thrombosis that occurred within the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous thrombosis (excluding those who were diagnosed as cured by researchers due to venous catheterization during early chemotherapy), and pulmonary embolism; 8. Any bleeding event with a severity rating of 3 or above in CTCAE4.0 occurred within 4 weeks prior to screening; Those with significant abnormalities in coagulation function and a tendency to bleed; Patients treated with warfarin, heparin, or their analogues; Under the premise that the international standardized ratio of prothrombin time (INR) is <= 1.5, it is allowed to use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (with a daily dose not exceeding 100 mg) for preventive purposes; 9. There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); Or it is necessary to use strong CYP3A4 inducers or CYP3A4 inhibitors for treatment; 10. A history of uveitis or iritis within 4 weeks; A history of retinal membrane disease within 12 months (neurosensory retinal detachment, retinal vein occlusion, or neovascular macular degeneration); 11. Previous history of organ transplantation; Having a history of immune deficiency, or suffering from other acquired or congenital immune deficiency diseases; Long term unhealed wounds or incomplete healing fractures; Known chronic lung diseases; Individuals who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders; 12. According to the judgment of the researchers, patients deemed unsuitable for entry into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Local control rate;HPA and HPT axis replacement therapy dosage;Visual Function;Cognitive function score;The accuracy of preoperative prediction of BRAF mutations in craniopharyngiomas.;The incidence and duration of diabetes insipidus after surgery.;Duration of surgery;Intraoperative tumor blood supply and texture; | — |
Countries
China
Contacts
Public ContactYao Zhao
Huashan Hospital, Fudan University
Outcome results
None listed