Patients with advanced gastric cancer, lung cancer, and osteosarcoma taking apatinib or antatinib
Conditions
Interventions
Gastric cancer group 1:Apatinib + thalidomide 50~150mg/d, po.QN
Gastric cancer group 2:Apatinib
Advanced NSCLC group 1:Anlotinib Hydrochloride + thalidomide 50~150mg/d, po.QN
Advanced NSCLC group 2:Anlotinib
Progressive osteosarcoma group 1:Apatinib + thalidomide 50~150mg/d, po.QN
Progressive osteosarcoma group 2:Apatinib
Progressive osteosarcoma group 3:Anlotinib Hydrochloride + thalidomide 50~150mg/d, po.QN
Progressive osteosarcoma group 4:Anlotinib
Sponsors
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with gastric cancer, non-small cell lung cancer, and soft-tissue sarcoma using analitinib/apatinib (at least one measurable lesion (according to RECIST 1.1 criteria)); 2) The body surface area of ??patients aged 14-70 years and 60 points; (Annex 3); 5) The main organ function meets the following criteria within 7 days before treatment: Blood test standard (without blood transfusion within 14 days): Hemoglobin (HB) = 90g/L (patients with anemia due to multiple metastasis of the tumor, haemoglobin =85g/L); Neutrophil absolute (NEU) = 1.5×10^9/L; Platelets (PLT) =80×10^9/L. Biochemical tests must meet the following criteria: total bilirubin (TBIL) = 1.5*ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5*ULN, and with liver metastasis, ALT and AST = 5*ULN; serum creatinine (Cr) = 1.5*ULN or creatinine clearance (CCr) = 60 ml/min; Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = normal lower limit (50%). 6) Expected survival period = 3 months; 7) Abnormal coagulation function, conventional treatment, dose may not change during the study; 8) Female patients need to have a negative pregnancy test; 9) There is no birth plan within 3 years and contraceptive measures are taken; 10) Patients voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Accompanied with pleural effusion effusion / ascitic fluid reaching more than 800ml or pleural effusion / ascites leading to respiratory syndrome (according to NCI CTC AE4.03 grade = 2 dyspnea; [Level 2 dyspnea refers to shortness of breath during a small amount of activity; impact on instrumental activities of daily living]]; 2. Except for intra-cervical in-situ cancer, non-melanoma skin cancer, and superficial bladder tumors that have occurred or currently have other malignant tumors within 5 years (Ta (non-invasive) tumors, Tis (in situ cancer) ) and T1 (tumor infiltrating basement membrane)); 3. Systemic anti-neoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitogens within 6 weeks prior to study drug treatment) planned within 4 weeks prior to enrollment or during the study medication C). Within 4 weeks prior to enrollment, extended field radiotherapy (EF-RT) or limited field radiotherapy of tumor lesions was performed within 2 weeks before enrollment; 4. Unresponsive toxicity above level 1 of CTC AE (4.03) due to any previous treatment, excluding hair loss; 5. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 6. Patients with brain metastases who have symptoms or symptoms less than 2 months of control; 7. Patients with any severe and/or uncontrolled disease, including: 1) patients with unsatisfactory blood pressure control (systolic blood pressure = 150 mmHg, diastolic blood pressure = 100 mmHg); 2) having grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc = 480 ms) and = grade 2 congestive heart failure (New York Heart Association (NYHA) classification); 3) active or uncontrollable serious infection (=CTC AE Level 2 infection); 4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) have a history of immunodeficiency, including those who are HIV positive or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 7) poorly controlled diabetes (fasting blood glucose (FBG)> 10 mmol/L); 8) Urinary cues suggest urinary protein = ++, and those who confirm 24-hour urine protein quantification> 1.0 g; 9) Patients with seizures and in need of treatment; 8. Major surgical treatment, biopsy or significant traumatic injury within 28 days before grouping; 9. Imaging studies show that the tumor has invaded important vascular weeks or that the investigator judges that the tumor is likely to invade vital blood vessels and cause fatal hemorrhage during follow-up studies; 10. Regardless of severity, there are any patients with bleeding signs or medical history; within 4 weeks before grouping, any patients with bleeding or bleeding = CTCAE grade 3 have unhealed wounds, ulcers, or fractures; 11. Hyperactivity/venous thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis, and pulmonary embolism within 6 months; 12. Patients with tumor thrombi; 13. patients with a single tumor longer than 20cm; 14. Those who have a history of psychotropic substance abuse and are unable to get rid of or have mental disorders; 15. Those who have a history of alcohol dependence and abuse and are unable to quit; 16. Four weeks of clinical tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of diarrhea;Incidence of bleeding;Incidence of myelosuppression;incidence of hand-foot syndrome;incidence of nausea;incidence of vomiting; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;progress free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Outcome results
None listed