Hepatocellular carcinoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 73 Years
Inclusion criteria
Inclusion criteria: 1. The patients aged 18 to 73 years, male or female; 2. The Eastern Cooperative Oncology Group (ECOG) score is 0-2, and the expected survival period is >=12 weeks; 3. High-grade glioma confirmed by pathology, grade III-IV (WHO); 4. All patients need to undergo surgical treatment, and no other anti-tumor therapy is given after surgery; 5. The presence of measurable or evaluable lesions; 6. The subject's baseline blood routine (without blood transfusion within 14 days) and biochemical indicators meet the following standards: (1) Hemoglobin >= 80 g/L; (2) Absolute neutrophil count (ANC) >= 1.5x10^9/L; (3) Platelet count >=80x10^9/L; (4) Total bilirubin =60ml/min. 7. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%). , 4 weeks before enrollment, the electrocardiogram was basically normal, and there was no clinically significant heart disease; 8. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days before study enrollment , and must be non-lactating patients; men should agree to patients who must use contraception during the study period and for 6 months after the end of the study period. 9. The patients were voluntarily enrolled and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. No pathologically confirmed high-grade glioma; 2. Those who are known to be allergic to temozolomide and donafenib tosylate, or have metabolic disorders; 3. Concurrent use of other experimental drugs or other clinical trials; 4. Patients with complete or incomplete disturbance of consciousness or poor control of persistent seizures; 5. Patients with severe liver disease (such as liver cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic system diseases; heart disease with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, drugs Uncontrolled arrhythmia, or myocardial infarction within 6 months, or cardiac insufficiency; 6. Those with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders; 7. Clinical serious infection higher than common adverse event evaluation standard (CTCAE) grade 2 in active stage; 8. Patients with other cancers other than malignant glioma within five years of the start of treatment in this study, excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumors [including Ta and Tis]; 9. Have a history of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); or have received long-term systemic steroid therapy (Note: short-term users can be selected if drug withdrawal > 2 weeks); 10. The second primary tumor; 11. Women who are pregnant, breastfeeding, women of childbearing age and their spouses refuse to take effective contraceptive methods; 12. Those who have no legal capacity, and those who have medical or ethical reasons that affect the continuation of research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Countries
China
Contacts
Public ContactLiu Junqi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed