castration-resistant prostate cancer after second-line treatment
Conditions
Interventions
castration-resistant prostate cancer after second-line treatment:Homoharringtonine injection
Sponsors
Zhongda Hospital affiliated to Southeast University
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: To be enrolled in this study, patients must meet all of the following inclusion criteria: 1. Age =18 years old, =85 years old; 2. ECOG score of physical condition 0 ~ 1; 3. Expected survival =6 months; 4. Prostate adenocarcinoma confirmed by histological or cytological examination without suggestive of neuroendocrine or small cell features; 5. Metastatic lesions demonstrated by imaging; Failure of at least 1 systemic drug therapy, such as progression with novel endocrine therapy (abiraterone, enzalulamide, apatamide, darrotamide), progression without genetic testing or progression with chemotherapy with PARPi, paclitaxel and beyond, and need for second-line therapy. 6. Progression of metastatic prostate cancer with castration was defined as at least one of the following three things: ?PSA progression, defined as at least two increases in PSA level (=1 week between each test), and PSA level at screening should be =1 ng/mL; ? Disease progression as defined in RECIST1.1; ? Progression of bone disease as defined by PCWG3 criteria, i.e., =2 or more new lesions found on bone scans; 7. Continued luteinizing hormone releasing hormone analogue (LHRHa) therapy (drug castration) or prior bilateral orchiectomy (surgical castration); Subjects who did not undergo bilateral orchiectomy must maintain effective LHRHa therapy for the first 4 weeks of the study and for the duration of the planned study; 8. At the time of screening, testosterone was at castration level (=50 ng/dL or 1.73 nmol/L); 9. The functional level of the organ must meet the requirements(no blood transfusion or hematopoietic growth factor treatment has been received within 2 weeks prior to blood routine screening) : ANC=1.5×109/L; PLT=80×109/L; Hb=90 g/L; TBIL=1.5×ULN; ALT and AST=3.0×ULN, 5.0×ULN if the subjects had liver metastasis; 10. Patients who are considered to be capable of ejaculation and sexually active must agree to take effective contraceptive measures and refrain from sperm donation within 3 months from the first administration to the last administration of the drug in this study; 11. Voluntarily participate in this clinical trial, understand the study procedures and have signed informed consent.
Exclusion criteria
Exclusion criteria: Interval after radiotherapy or surgery less than 3 weeks, or participated in the other drug clinical trial less than 4 weeks ago Did not recovered for previous anti-tumor treatment toxicity. Irreversible toxicity reasonably expected not to be aggravated by the drug under study (e.g., hearing loss) may be included in the study; Existence of metastasis of the central nervous system (CNS) Poorly controlled hypertension (systolic blood pressure >150 MMHG or diastolic blood pressure > 90 MMHG with medication); Serious cardiovascular events within 6 months prior to randomisaztion: a) Myocardial infarction b) Unstable angina pectoris c) Heart angioplasty or stenting d) Coronary/peripheral artery bypass graft e) Grade ? or ? congestive heart failure as defined by the New York Heart Association f) Cerebrovascular accident or transient ischemic attack QT (QTc) =480 msec; History of active bleeding or any other serious hemorrhage within 30 days before randomisation, deep vein thrombosis or pulmonary embolism 6 months prior to randomisation; Allergic to HHT or Auxiliary material in the injection Need systemic treatment of active infection, the human immunodeficiency virus (HIV) infection HIV antibody positive (known), active HBV and HCV infection (HBsAg positive people, or HBcAb positive but HBsAg negative, need to add DNA quantitative measurement, Those whose results do not exceed the upper limit of the normal laboratory value of the research center can participate in this study; Those infected with HCV in the screening period with negative HCV RNA test results can participate in this study; Need systemic treatment of other active infection;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overal survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progression Free Survival);DCR (Disease Control Rate);OS (Overall Survival);Safety; | — |
Countries
China
Contacts
Public Contactchen ming
Zhongda Hospital affiliated to Southeast University
Outcome results
None listed