Metastatic Castration-Resistant Prostate Cancer
Conditions
Interventions
experimental group:Camrelizumab combined with Apatinib mesylate and Fluzoparib
Sponsors
Chinese PLA General Hospita
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up; 2. Patients aged 18-75 years (including boundary value, calculated on the day of signing informed consent); 3. Patients with metastatic castration resistant prostate adenocarcinoma confirmed by pathology can cooperate with blood sample collection, tumor tissue biopsy and / or provide enough tissue samples for biomarker detection; 4. Patients with testosterone level = 1ng / ml in screening period; 6. ECoG score: 0-1; 7. Patients with expected survival time >= 12 weeks; 8. Patients whose functions of important organs meet the following requirements (no blood components and cell growth factors are allowed to be used within 14 days before the first medication): absolute count of neutrophils >= 1.5 * 10 ^ 9 / L; platelets >= 100 * 10 ^ 9 / L; hemoglobin >= 10 g / dl; serum albumin >= 3 g / dl; bilirubin <= 1.5 times ULN; ALT and AST <= 3 times ULN; serum creatinine <= 1.5 times ULN; serum creatinine <= 1.5 times ULN; 9. The subjects and their partners have potential fertility potential and need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune disease or history of autoimmune diseases (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma has been completely relieved in childhood, and no intervention is required in adults; patients Asthma that needed bronchodilators for medical intervention could not be included; 2. Patients who are using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dosage > 10mg / D, prednisone or other effective hormones) and continue to use them within 4 weeks before enrollment; 3. Previous (within 5 years) or at the same time suffering from other malignant tumors, except for skin basal cell carcinoma which has been cured; 4. The subjects had previously used PARP inhibitors, including but not limited to olapali, nilapali and lukapali; or had previously used apatinib; or had received platinum containing chemotherapy; or had previously received anti PD-1, PD-L1 antibody therapy; or had been treated with anti-PD-1 and PD-L1 antibodies; 5. Patients who are known or suspected to be allergic to the study drug or any drug related to this trial; 6. Patients with cancerous meningitis or untreated central nervous system metastasis; those who have previously received systemic, radical brain or meningeal metastases (radiotherapy or surgery), whose stability has been maintained for at least 1 month and who have stopped systemic hormone therapy (dosage > 10mg / D, prednisone or other effective hormones) for more than 2 weeks and without clinical symptoms can be included; 7. The patient has or is about to develop spinal cord compression, unless clinically stable and asymptomatic after appropriate treatment. 8. Patients with intestinal obstruction and gastrointestinal perforation recently (within 3 months); 9. Patients who cannot swallow the tablets normally or have gastrointestinal dysfunction, which may affect drug absorption according to the researcher's judgment; 10. Ascites and pleural effusion with clinical symptoms, who need puncture and drainage, or who have received ascites and pleural effusion drainage within one month before the first trial medication; 11. Patients with bone pain that can not be controlled effectively; 12. Patients with hypertension who cannot be well controlled by antihypertensive drugs (SBP >= 140 mmHg or DBP >= 90 mmHg); 13. There are clinical symptoms or diseases of the heart that are not well controlled, for example: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; (5) QTc > 450ms (male); QTc > 470ms (female); 14. Patients with any bleeding event with severe grade 2 or above in CTCAE 5.0 within 4 weeks before the first trial medication; 15. Patients with previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and tissue pneumonia (such as bronchitis, obliterans), drug-induced pneumonia, or active pneumonia in screening period; 16. Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy are allowed to receive low-dose low-molecular-weight heparin or o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerance Dose;Dose Limited Toxicity;??????? Comprehensive assessment of remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA-TTP;PSA-DOR;rPFS;rTTP;PFS;12 month OS rate;AE;PK;Biomarker; | — |
Countries
China
Contacts
Public ContactXu Zhang
Chinese PLA General Hospital
Outcome results
None listed