Castration-Resistant Prostate Cancer
Conditions
Interventions
Case Series:Autologous RAK cells combined with Abirone
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. In patients with advanced prostate cancer diagnosed histologically as prostate adenocarcinoma, serum testosterone level is below castration level; 2. Had or did not have any measurable lesion (per RECIST 1.1 criteria); 3. Patients with metastatic prostate cancer who have failed first-line endocrine therapy or who have progressed after chemotherapy, including imaging progress or PSA progress, are to be treated with abitron; Criteria for PSA progression: the PSA value was more than 20% of the lowest value during the previous treatment, and the absolute value was higher than the lowest value 2ng/ml, and was confirmed after 3 weeks. Criteria for imaging progression: soft tissue lesions were assessed as tumor progression on RECIST criteria, or bone scans suggested the presence of one or more new lesions. 4. Male Aged 18 to 85 years; ECOG PS score: 0~2; The expected survival time is more than 3 months; 5. The end time of the previous anti-tumor treatment should be more than 4 weeks, including cytotoxic drugs, endocrine therapy, radiotherapy and surgery; 6. The main organs function normally, that is, they meet the following criteria: (1) Blood routine examination standards should meet: ? HB 90g/L (no blood transfusion within 14 days); ? WBC acuity 3.0 x 109 / L; ? PLT acuity 80 x 109 / L (2) Blood biochemical examination shall meet the following standards: ? TBIL 1.5 times the normal value of the upper limit (ULN); ? ALT and AST 2.0 times ULN;In the case of liver metastasis, ALT and AST were less than or equal to 5 times ULN. ? Cr 1.25 times ULN or creatinine clearance (CCr) 60ml/min; (3) Cardiac doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) normal value lower limit (50%). 7. Patients volunteered to participate in this study and signed the informed consent, with good compliance.
Exclusion criteria
Exclusion criteria: 1. Previous use of anti-angiogenesis targeted drug therapy for metastatic castration-resistant prostate cancer, such as carbotinib, sunitinib, sorafenib, etc.; 2. Patients with any severe and/or uncontrolled disease, including: ? The largest antihypertensive treatment of blood pressure control is still not ideal (systolic blood pressure > 160 MMHG, diastolic blood pressure > 100 MMHG) patients.There was a history of angina attack and cerebral ischemia in the past 3 months. ? Active or failed to control severe infection; ? liver diseases such as decompensated liver disease, chronic active hepatitis, etc ?poor control of diabetes (FBG) > 10mmol/L) ?urine routine examination indicated urine protein=++ and confirmed the hourly urine protein quantitative > 1.024g 3. A wound or fracture that has not been healed for a long time; 4. Patients with bleeding tendency (e.g. active peptic ulcer) or who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 5. Have a history of psychotropic substance abuse and cannot quit or have mental disorder; 6. Patients who have participated in clinical trials of other anti-tumor drugs within 4 weeks; 7. Have a history of immune deficiency, including hiv-positive or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 8. According to the judgment of the researcher, those who seriously endanger the safety of patients or affect the patients' concomitant diseases in completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival rate;Prostate specific antigen; | — |
Countries
China
Contacts
Public ContactJie Ma
Beijing Hospital
Outcome results
None listed