Pituitary adenoma
Conditions
Interventions
Experimental group:Apatinib tablet, 500mg, once a day
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old = 70 years old, regardless of gender; (2) Clinically and pathologically diagnosed pituitary adenoma, and able to obtain pathological tissue (wax tissue or frozen tissue); Proteomic sequencing confirmed SF1/NULLenrich subtype with high expression of VEGFR2; (3) Residual tumor after initial surgery, or tumor recurrence, making it difficult to completely remove the tumor after another surgery; (4) Radiotherapy has been performed with poor efficacy, or the subject refuses radiation therapy; (5) Expected survival time = 6 months; (6) KPS score = 70 points; (7) Able to read, understand, and sign a written informed consent form before participating in the study, and willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: (1) Within one month prior to screening, the subject has participated in clinical studies of other drugs or medical devices; (2) Individuals who are known to be allergic to the study drug; (3) Diagnosed as pituitary adenocarcinoma or combined with other malignant tumors; (4) Individuals with severe acute and chronic diseases of various systems that have not been effectively controlled or have unstable conditions, including but not limited to: patients with cardiac insufficiency (NYHA cardiac function rating = 2), uncontrolled cardiomyopathy, coronary heart disease, severe arrhythmia, and other serious heart diseases; Severe active infection; Uncontrollable diabetes, hypertension/hypotension, cerebrovascular disease, gastric ulcer, respiratory disease, active autoimmune disease, etc; Any other medical history of diseases judged by the researcher as unsuitable for participation in this experiment; (5) Patients with liver and kidney dysfunction, total bilirubin>1.5 × ULN, ALT, AST > 2.5 × ULN; Blood creatinine>2 × ULN; (6) Neutrophil count<1.5 × 10^9/L, or platelet count<100 × 10^9/L, or HGB < 90g/L; (7) Pregnant, lactating women or those who are unwilling to use contraception during the trial period; (8) Researchers believe that there are other factors that are not suitable for participating in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy rate ;Progression free survival;KPS score ;clinical symptoms;Pituitary associated endocrine function; | — |
Countries
China
Contacts
Public ContactYao Zhao
Huashan Hospital, Fudan University
Outcome results
None listed