Craniopharyngioma
Conditions
Interventions
experimental group :Medication
control group:None
Sponsors
Department of Neurosurgery, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed craniopharyngioma or with pathologically confirmed recurrent craniopharyngioma; 2. The enrolled subjects are adults, regardless of gender, and the enrolled aged 18 years old; 3. The newly diagnosed subjects who had not undergone surgery or the recurrent subjects who had only received surgery had entered the group A, and the subjects who had received the previous radiation therapy entered group B. For group A subjects, the time from the last surgery was greater than 1 month. For group B subjects, the enrollment must be completed more than 3 months from the last radiotherapy; 4. Subjects required measurable tumor lesions in imaging findings. That is, the tumor has a clear boundary with a minimum diameter of 1 x 1 cm in a two-dimensional plane; 5. The subject has not received any treatment for a small molecule targeted anti-tumor inhibitors; 6. Female subjects enrolled in the group should be pregnant or lactating. For the fertile female of childbearing age, the pregnancy test is negative within the week before enrollment. Female who are of childbearing age must be enrolled in effective contraception until 6 months after discontinuation; 7. The subjects had no serious comorbidities (1) No serious blood system diseases, such as leukemia, aplastic anemia, etc., hemoglobin >90g / L during enrollment and medication, absolute neutrophil count >1.5X10^9/L, platelets greater than 100X10^9 / L. There was no potential risk of active bleeding and bleeding within 2 months prior to enrollment, and no intracranial hemorrhage occurred within 1 month; (2) If a thromboembolic event occurs within 6 months prior to enrollment, the anticoagulant therapy is stable for at least 1 month; (3) No drug-refractory hypertension before enrollment (standardized antihypertensive therapy still has a blood pressure greater than 150/95 mmHg); (4) Asymptomatic congestive heart failure occurred within 6 months prior to enrollment, and the grade was no more than grade 1. No acute coronary syndrome occurred within 6 months prior to enrollment, including myocardial infarction and unstable angina, coronary artery bypass grafting or stent placement; (5) There was no history of severe arrhythmia, no long QT syndrome, no history of ventricular arrhythmia in the first 6 months of enrollment, and there was no arrhythmia that could not be controlled; (6) There was no history of retinal detachment or high-risk pathological evidence of shedding within 12 months prior to enrollment. There is no retinal vein occlusion or neovascularization or macular degeneration; (7) No history of chronic lung disease; (8) No history of digestive diseases, such as short bowel syndrome, does not affect the absorption of oral medications; (9) No history of severe liver and kidney disease, bilirubin levels no more than 1.5 times normal high values, alkaline phosphatase levels no more than 2.5 times normal high values, AST or ALT levels no more than 2.5 times normal high values, creatinine The level does not exceed 1.5 times the normal high value, and the creatinine endogenous clearance rate is >50 ml/min; 8. Volunteer to participate in the clinical trial, sign informed consent, and have good medical skills. 9. Subjects who have no relevant medication contraindications, who voluntarily take the drug and are able to pay for the drug.
Exclusion criteria
Exclusion criteria: (1) The subject is in an endangered condition that is unable to take medication, such as a disturbance of consciousness or inability to eat; (2) Other invasive tumors within 3 years, except for certain cured tumors or precancerous lesions, such as cervical carcinoma in situ, early thyroid cancer; (3) Other drugs that conflict with the pharmacological action of the drug or affect the absorption of the drug must be used; (4) There are clear drug contraindications, allergic reactions with similar ingredients used in the previous treatment or obvious adverse reactions during the medication must be discontinued; (5) The subjects were pregnant or lactating women and could not take the inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum diameter of tumor;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hormone levels;Vision and Visual fields; | — |
Countries
China
Contacts
Public ContactJianguo Xu
West China Hospital, Sichuan University
Outcome results
None listed