metastatic castration-resistant prostate cancer ( mCRPC )
Conditions
Interventions
experimental group:Disitamab Vedotin combine ADT
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily joined the study and signed informed consent ; 2.Age = 18 years ; 3.Prostate adenocarcinoma confirmed by histology or cytology, excluding patients with small cell carcinoma or other special types of prostate cancer ( non-acinar cell carcinoma ) ; immunohistochemistry ( IHC ) was used to detect the expression of HER2 in tumor tissues as IHC 0,1 +, 2 + or 3 + ; 4.There are metastatic lesions recorded by whole body bone scan and / or soft tissue CT / MRI and / or PET-CT ; 5.ECOG score 0-2 ; 6.Predicted survival time = 3 months ; 7.Standard disease progression after treatment ( according to the criteria of prostate cancer clinical trial working group 3 ), patients must consider metastatic castration-resistant prostate cancer ( mCRPC ) for at least one new endocrine therapy drug ( such as abiraterone or enzalutamide ) and docetaxel treatment failure or not suitable for docetaxel treatment ; 8.Continuous maintenance of ADT treatment ( surgery or drug castration ), and maintain testosterone levels = 50ng / dL ; according to the PCWG3 standard, prostate cancer progression was recorded within 6 months before screening, including at least the following : PSA progression : defined as at least 2 times of PSA level increase, and the interval between each determination was = 1 week. The PSA value at screening visit should be = 2ug / L ( 2ng / mL ). Soft tissue progression based on RECIST 1.1 criteria. Based on two or more new bone lesions found by whole body bone scan or PET-CT. 9. Normal function of major organs, i.e. meeting the following criteria: 1) The standard for blood routine examination must comply with (no blood transfusion or blood products within the first 14 days, no correction using G-CSF or other hematopoietic stimulating factors): hemoglobin (HB) = 80 g/L; Neutrophil absolute value (ANC) = 1.5 × 109/L (1500/m3); Platelet count (PLT) = 100 × 109/L; International standardized ratio or activated partial thromboplastin time = 1.5 upper limit of normal value (ULN); 2) Biochemical examination must meet the following standards: total bilirubin (TBIL) = 1.5 × ULN. If Gilbert syndrome or indirect bilirubin concentration shows an increase in extrahepatic bilirubin, it should be = 3 × ULN. For subjects with liver metastasis, TBIL = 3 × ULN; ALT and AST = 2.5 × ULN, while for liver metastasis subjects, ALT and AST = 5 × ULN; Alkaline phosphatase = 3 times ULN (if liver or bone metastasis occurs, ALP = 5 times ULN); Serum creatinine (Cr) = 1.5 x ULN or creatinine clearance rate (CrCl) = 60 ml/min (Cockcroft Goult formula: CrCL (mL/min)=[(140 age) * body weight (kg) * F]/(SCr (mg/dL) * 72). Among them, F=1 for males, F=0.85 for females, and SCr=serum creatinine); 3) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) = lower limit of normal value (50%);
Exclusion criteria
Exclusion criteria: 1. patients with other malignant tumors ; 2.Subjects with active brain metastasis ; 3.Study of large-scale surgery or radiation therapy within 4 weeks before the start of administration ; 4.New York Heart Association ( NYHA ) grade 3 and above heart failure ; 5.Patients with grade 3 and above peripheral neurotoxicity in previous chemotherapy ; 6.There are systemic diseases that are judged by researchers to be uncontrolled, including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc. ; 7.There is a history of allergic reactions to any drug used in this study ; 8. according to the researchers, the patient may have other factors that lead to the forced termination of the study, such as other serious diseases or serious laboratory abnormalities or other factors that affect the safety of the subjects, or family or social factors such as test data and sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactXinhua Tu
Jiangxi Cancer Hospital
Outcome results
None listed