Brain stromal tumor
Conditions
Interventions
Case series:Concurrent radiotherapy with arotinib: the subjects were treated with radiotherapy, and they were treated with oral administration of 12 mg of arotinib once a day, once a day for 2 weeks a
Sponsors
Cancer center of Union Medical College Affiliated to Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. aged 18 to 70 years old; 2. The histologic diagnosis of glioblastoma was grade IV by who; 3. After surgical treatment of glioblastoma; 4. MGMT promoter methylation was negative by PCR or NGS; 5. In the past, they did not receive any tumor specific treatment other than surgery for glioblastoma; 6. ECoG physical status was 0-2 points; 7. The function of the main organs is normal, that is to say, it meets the following standards: (1) Blood routine examination standard should meet: (no blood transfusion within 14 days) Hb>=90g/L; ANC.=1.5x10^9/L; PLT>=80x10^9/L; (2) Biochemical examination should meet the following standardsL Bil 50ml/min (Cockcroft gaut formula); 8. Sign written informed consent prior to any trial related activities; 9. The researcher judged that the protocol could be followed; 10. The pregnancy test (for women with fertility) was negative at the time of screening; 11. Fertile male patients, as well as women with fertility and pregnancy risk, must agree to use two contraceptive methods (at least one of which is considered to be highly effective) throughout the study period. Female patients without fertility (i.e. meeting at least one of the following criteria): - have undergone hysterectomy and / or bilateral oophorectomy and are documented; - medically confirmed ovarian decline; - postmenopausal status, defined as menopause for at least 12 months without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) level is consistent with postmenopausal status. A signed and dated informed consent form indicating that the patient (or legal representative, if permitted by local guidelines / practices) has been informed of all relevant aspects of the study. 12. Patients are willing to follow the treatment schedule and other treatment plans.
Exclusion criteria
Exclusion criteria: 1. He has received anti angiogenic drugs with anti VEGF targets in the past; 2. Other malignancies have occurred or are currently suffering from other malignancies within 5 years, except for the cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 3. Within 28 days before randomization, there were definite bleeding tendency or bleeding symptoms with significant clinical significance, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis and retractive epistaxis), and persistent hemorrhagic diseases or coagulation disorders; 4. Patients who had hemoptysis or hemoptysis within 28 days before randomization (defined as coughing or coughing up more than 1 teaspoon of blood or small blood clot or only hemoptysis without sputum) within 28 days before randomization; 5. Within 28 days before randomization, the imaging showed that the tumor surrounded the important vessels, and the researchers determined that the risk of bleeding would be caused by entering the study; 6. Subjects known to be allergic to amlotinib hydrochloride capsules or chemotherapy drugs involved in this study; 7. Received systemic immunomodulators (including but not limited to interferon and interleukin-2) within 28 days before randomization; 8. Any one of the following severe acute complications occurred before randomization: (1) Unstable angina pectoris and / or congestive heart failure or vascular disease (e.g., aortic aneurysm or peripheral venous thrombosis requiring surgical repair) requiring hospitalization within 12 months, or other cardiac damage (such as poorly controlled arrhythmias, myocardial infarction or ischemia) that may affect the safety evaluation of the study drug as judged by the investigator; (2) There were esophageal and gastric varices, ulcer, wound or fracture within 6 months; (3) There was a history of abdominal fistula, gastrointestinal perforation, abdominal abscess or acute gastrointestinal hemorrhage within 6 months; (4) Within 6 months, there were arterial thromboembolism events, venous thromboembolism above NCI CTCAE grade 3, transient ischemic attack (TIA), cerebrovascular accident (CVA), hypertensive crisis or hypertensive encephalopathy; (5) Severe chronic obstructive pulmonary disease (COPD) or other respiratory diseases requiring hospitalization within 28 days; (6) Active pulmonary infection and / or acute bacterial or fungal infection requiring intravenous antibiotic treatment within 28 days; (7) There was dominant jaundice caused by abnormal liver function within 7 days; (8) Minor surgical procedures (including catheterization, excluding peripherally inserted central venous catheterization) were performed within 2 days; (9) At present, they are suffering from hypertension and can not be well controlled by single antihypertensive drugs (systolic blood pressure >=160 mmHg, diastolic blood pressure >=100 mmHg); or they are using two or more antihypertensive drugs in combination; 9. Virological tests during the screening period show that any of the following conditions are met: (1) HBsAg positive and HBV DNA titer >=1x10^3 copies/L in peripheral blood; (2) Anti HCV was positive; (3) HIV positive; 10. Participated in clinical trials of other antitumor drugs within 28 days before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactYang Kunyu
Union Medical College Affiliated Hospital of Tongji Medical College, Huazhong University of science and technology
Outcome results
None listed