solid tumor
Conditions
Interventions
experimental group:enrotinib hydrochloride and temozolomide
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age ranged from 18 to 75 years old; 2. ECoG PS score was 0-2; 3. KPS score >= 60 points; 4. The expected survival time was more than 3 months; 5. According to the WHO (2013 Edition) tumor classification, the pathological types of primary tumors mainly include: Lung cancer (NSCLC, SCLC), breast cancer, melanoma, renal cell carcinoma, and other pathological types (digestive tract malignant tumor, etc.) were assessed by the researchers; 6. Patients who failed in standard treatment; 7. There was at least one measurable lesion >= 1 cm; 8. The function of main organs was normal and the following criteria were met within 7 days before treatment 1) Blood routine examination standard should meet (no blood transfusion and blood products, no correction of G-CSF and other hematopoietic stimulating factors) within 14 days a) Hemoglobin (HB) >= 90g / L; b) The absolute value of neutrophil (ANC) >= 1.5 x 10^9 / L; c) Platelet (PLT) >= 75 x 10^9 / L 2) Biochemical examination should meet the following standards: a) Total bilirubin (TBIL) = 60ml / min; 3) Urinary protein = the lower limit of normal value (55%); 6) Thyroid function: TSH <= upper limit of normal value (ULN); if abnormal, FT3 and FT4 levels should be considered; if FT3 and FT4 levels are normal, they can be enrolled; 9. Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and have negative results, and are willing to use appropriate methods of contraception or have been sterilized during the trial and 8 weeks after the last administration of the trial drug. For men, they should agree to use appropriate contraceptive methods or have been sterilized during the trial and 8 weeks after the last administration of the trial drug; 10. With my consent, I signed the informed consent, and the compliance was good.
Exclusion criteria
Exclusion criteria: 1. Patients with meningeal metastasis or spinal cord tumor; 2. He had received anti-tumor treatment, including radiotherapy and surgery, and had received the combination therapy of "anlotinib + temozolomide" in the past 4 weeks; 3. Other malignant tumors were diagnosed within 3 years before enrollment and underwent radical surgery 5 years before enrollment; 4. Patients with severe allergy to enrotinib hydrochloride and temozolomide; 5. History of any active immune or autoimmune disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment; 7. Active or uncontrolled severe infection (>= CTC AE 2 infection) occurred within 4 weeks before enrollment; 8. Hypertension history, and can not get good control after drug treatment (SBP >= 140mmHg or DBP >= 90mmHg); 9. Urine routine examination showed that urine protein was >= + + +, and 24-hour urine protein was more than or equal to 1.0 G; 10. HIV positive, liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment; 11. The following cardiovascular diseases occurred within 6 months before enrollment: Grade II myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450 ms in male and >= 470 MS in female); grade III to IV cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) less than 50% according to NYHA standard; 12. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with active bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 13. Patients with significant clinical bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic hemorrhoids, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or patients with vasculitis; patients with any signs of bleeding constitution or history, regardless of the severity; 14. Within 4 weeks before grouping, patients with any bleeding or bleeding events >= CTCAE 3 underwent major surgery or developed severe traumatic injury, fracture or ulcer; 15. Pregnant or lactating women; fertile patients who are unwilling or unable to take effective contraceptive measures; 16. Any unrelieved toxic reactions higher than CTC AE (5.0) 1 caused by previous treatment, excluding alopecia. 17. Those who have a history of abuse of psychotropic drugs and can not quit or have mental disorders; According to the investigator's judgment, there are serious hazards to the patient's safety, which may confuse the research results, or affect the patients to complete the study or any other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;disease control rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactSong Min
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed