Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC

Korábbi kezelés

• Previously received any PARPi treatment for prostate cancer (including but not limited to Olaparib, Nilaparib, Terazopanib, Lucaparib, etc.)
• Other clinical trial drug treatments and major surgeries received within the 4 weeks prior to randomization in this study
• There are factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect medication intake and absorption
• Have a history of epilepsy or have experienced a disease that can trigger epileptic seizures within the 12 months prior to randomization (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization)
• Patients with other malignant tumors within the past 3 years prior to randomization (excluding in situ cancer that has completely resolved and malignant tumors judged by researchers to have slow progression)

Más betegség

• Active heart disease within the first 6 months of randomization, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (heart function class III or IV), and drug-induced ventricular arrhythmias
• Individuals with active HBV and HCV infection (HBsAg positive and virus copy number ≥ 500 IU/mL, HCV antibody positive and HCV RNA above the detection limit of the analytical method)
• Individuals with a known history of allergies to Fluzopanib and Abiraterone nanocrystals and their components

Laborértékek

• Individuals with a history of congenital immunodeficiency or organ transplantation, or HIV positive subjects who meet one or more of the following criteria: Not receiving highly effective antiretroviral therapy; Change antiretroviral therapy within 6 months prior to the start of screening; • Undertaking antiretroviral therapy that may interfere with the investigational drug (please consult the sponsor before enrollment); CD4 count<350/mm3 during screening; Opportunistic infections that meet the definition of acquired immunodeficiency syndrome occurred within the 12 months prior to the start of screening

Egyéb

• The researchers determined that participants with ejaculation ability and sexual activity were unwilling to take the contraceptive measures specified in the protocol during the entire study treatment period and within 3 months after the last dose

• Age ≥ 18 years old, male
• ECOG score is 0 or 1
• Untreated first-line metastatic castration resistant prostate cancer patients
• Allow the use of a new endocrine drug treatment once during hormone sensitive stages
• The organ function level must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy received within 2 weeks before blood routine screening): ANC ≥ 1.5 × 109/L PLT≥100×109/L； • Hb≥90 g/L； • TBIL ≤ 1.5 × ULN (excluding subjects with Gilbert syndrome) • ALT and AST ≤ 2.5 × ULN; • Cr≤1.5×ULN； • LVEF≥50%； • QTcF≤450 ms。
• If the partner is a subject with fertility, they should undergo surgical sterilization or agree to receive it during and at the end of the trial period
• Sign a written informed consent form and expect good compliance with the research protocol