advanced malignant tumors
Conditions
Interventions
Experimental group:Thalidomide+zoledronic acid
Sponsors
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically diagnosed as prostate, breast, or non-small cell lung cancer with radiographically confirmed bone metastases or with bone pain, fractures, etc., and meet the following conditions; (1) No radiotherapy for the first 3 months of treatment, and no radiation therapy is expected during the study period (6 months); (2) Hb drops to Level II (60 ? Hb ? 90 g/L, Annex 1); 2. Age 18 to 70 years old, male or female; 3. Physical status score, KPS score >60 points; (Annex 3) 4. Expected survival period = 6 months; 5. Coagulative function is normal; or mild abnormality (CTC AE 4.03 Class I), recovered after treatment; 6. No erythropoietin or other erythrocyte-promoting drug was administered within 4 weeks before the test, and no history of blood transfusion (whole blood or red blood cells) within 4 weeks 7. Women of childbearing age have no birth plans during the study period and within 12 months after the last medication and are willing to take contraceptive measures; 8. The patient understands the purpose and test procedure of the trial, voluntarily participates in the trial, and signs written informed consent; 9. Patients are willing and able to follow study visit plans and other program requirements. 10. Partial Relief (PR).
Exclusion criteria
Exclusion criteria: 1) Patients who have participated in clinical trials of thalidomide tablets; 2) Must be taking myelosuppressive drugs due to other conditions; 3) Positive pregnancy test in female patients; 4) With renal anemia; 5) Those who have a history of chronic blood disease; 6) Other chronic bleeding; 7) Those who are previously neurotoxic; 8) Those who are allergic to thalidomide, lenalidomide or dexamethasone; 9) Accompanied with pleural effusion effusion/abdominal fluid reaching more than 800ml or pleural effusion/ascites leading to respiratory syndrome (according to NCI CTC AE4.03 grade = 2 dyspneas. [Grade 2 dyspnea refers to shortness of breath during a small amount of activity; Impact on instrumental activities of daily life]); 10) 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)]; 11) Alopecia is not included because of any unresponsive toxicity above CTC AE (4.03) caused by any previous treatment; 12) Have various factors affecting oral medications (such as inability to swallow and intestinal obstruction); 13) Imaging has confirmed patients with brain metastases or brain metastases with symptoms or symptoms less than 2 months; 14) Patients with any severe and/or uncontrolled disease, including: a) patients with unsatisfactory blood pressure control (systolic blood pressure = 150 mmHg, diastolic blood pressure = 100 mmHg); b) 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); c) Severe liver and kidney abnormalities (AST, ALT> 5 times upper limit of normal, total bilirubin> 1.5 times upper limit of normal, SCr> 1.5 times upper limit of normal); 15) Major surgical treatment, open biopsy or significant traumatic injury within 28 days before grouping; 16) Imaging studies show that tumors invade vital blood vessels or that the investigator judges that the tumor is likely to invade vital blood vessels and cause fatal hemorrhage during follow-up studies; 17) 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; 18) Hyperactivity / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism within 6 months; 19) Patients with tumor thrombi; 20) Patients with a single tumor longer than 20cm; 21) Those who have a history of psychotropic substance abuse and are unable to get rid of or have mental disorders; 22) Those who have a history of alcohol dependence and abuse and are unable to quit; 23) Accompanied by other tumor or blood system diseases; 24) Simultaneous use of other erythrocyte-enhancing drugs, including traditional Chinese medicines (such as ejiao), or participation in other clinical trials within four weeks; 25) According to the investigator's judgment, there are comorbid diseases that seriously endanger the patient's safety or affect the patient's completion of the study; 26) Patients not considered suitable for clinical trials by other researchers; 27) Peripheral neuropathy (PN) = 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Outcome results
None listed