The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas

This is an interventional treatment trial for Pituitary Adenomas focused on measuring Temozolomide; radiotherapy; refractory pituitary adenomas Read More

Inclusion Criteria:

Minimum Age: 18 Years Maximum Age: 80 Years

1. Age ≥18 years, regardless of gender;

2. Meet the diagnostic criteria for refractory pituitary tumors;

   1. The tumor showed invasive growth on imaging and rapid growth, Ki-67 labeling index ≥3%;
   2. The tumor recurred within a short period of time (< 6months) after total resection;
   3. The tumor continues to grow after surgery and medical therapy;
   4. Systemic examination showed no metastases in the cranial canal or other systems throughout the body.
3. Clinicopathological diagnosis of pituitary adenoma, and pathological tissue (wax or frozen tissue) can be obtained;
4. Expected survival time ≥ 6 months;
5. KPS score ≥70 points;
6. Subjects who were able to read, understand, and sign written informed consent prior to participating in the study and were willing to comply with protocol requirements.

Exclusion Criteria:

Participants cannot participate in this study if they meet any of the following conditions:

1. Subjects participated in clinical studies of other drugs or medical devices within 3 months before screening.
2. Known to be allergic to temozolomide capsules;
3. Have been diagnosed with pituitary carcinoma or have other malignant tumors;
4. Have received radiation therapy for Sella region;

5. Those with severe acute and chronic diseases in various systems, whose conditions have not been effectively controlled, and whose conditions are unstable, including but not limited to:

   1. Patients with cardiac insufficiency (NYHA cardiac function grade ≥ 2), patients with severe heart disease such as cardiomyopathy, coronary heart disease, severe arrhythmia, etc. that are not effectively controlled;
   2. Severe active infections,
   3. Uncontrollable diabetes, hypertension / hypotension, cerebrovascular disease, gastric ulcer, respiratory disease, active autoimmune disease, etc .;
   4. History of any other diseases that the researcher judges to be unsuitable for the trial, etc .;
6. For hepatic and renal insufficiency, hematological indicators: total bilirubin> 1.5 × ULN, ALT, AST> 2.5 × ULN; serum creatinine> 2 × ULN;
7. Those with a neutrophil count of less than 1.5 × 109 / L, or a platelet count of less than 100 × 109 / L, or an HGB of less than 90g / L;
8. Hepatitis B surface antigen, anti-HCV, anti-HIV or syphilis antibody positive;
9. Those who need to take valproic acid and drugs that can cause bone marrow depression during the application or research period;
10. pregnant or lactating women or those planning to become pregnant;
11. People with history of difficulty in drawing blood;
12. People with a history of bleeding disorders;
13. Subjects had a history of drug use or smoking and alcohol abuse within 6 months before enrollment;
14. Researchers do not consider it appropriate to participate in the trial.