EUCTR2018-003190-96-BG进行中（未招募）1 期
One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 572
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Age ?18 years, male;
- •- Performance status ECOG scores 0-1;
- •- Histologically or cytologically confirmed adenocarcinoma of the prostate, and no neuroendocrine differentiation or small cell features;
- •- High tumor load, i.e., the radiological examination meets at least one of the following conditions: 1) ?4 bone metastatic foci are found in Tc-99m bone scan (at least one focus not in pelvis or spine); 2) visceral metastasis is shown in CT/MRI (not including lymph node);
- •- Plan to receive or maintain ADT in study period, i.e., continuous use of luteinizing hormone releasing hormone analogue (LHRHA) (drug castration) or previous bilateral orchidectomy (surgical castration);
- •- Being unable to tolerate or not willing to receive chemotherapy;
- •- The organ function level must meet the following requirements:
- •ANC?1.5×109/L;
- •PLT?100×109/L;
- •TBIL?1.5×ULN;
- •ALT and AST ?2.5 × ULN;
- •BUN(or UREC) and Cr?1.5×ULN;
- •- Ability to comply with the study protocol as judged by the investigator;
- •- Being voluntary to participate in this clinical trial, understanding the study procedure and being able to sign the written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 230
排除标准
- •- Previous ADT, chemotherapy, surgery, external irradiation, brachytherapy, radiopharmaceutical or investigational local therapy (e.g., radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.) for prostate cancer
- •- Previous use or plan to use the second generation androgen receptor antagonist (e.g., enzalutamide, ARN-509, ODM-201), ketoconazole, Abiraterone Acetate or other drugs medicines uder development inhibiting synethsis of androgen (e.g., TAK-700) for treatment of prostate cancer during study treatment;
- •- Having received the following therapies within 4 weeks prior to C1D1:
- •? 5a-reductase inhibitor (e.g., Finasteride, dutasteride);
- •? Estrogen, Progesterones, androgen, systemic steroids (except temporary use for anti-allergic purpuse);
- •? Plant medicine with known anti-prostate cancer or PSA-lowering effect (e.g., Saw Palmetto);
- •? Other study treatment in clinical trials.
- •- Presence of radiologically confirmed central nervous system lesions;
- •- Plan to receive any other antitumor therapies during this trial;
- •- History of known allergy to the components of SHR3680 tablet or Bicalutamide tablet;
- •- Inability to swallow, chronic diarrhea and intestinal obstruction, presence of multiple factors affecting drug intake and absorption;
- •- History of epilepsy, or diseases that can induce epileptic seizure within 12 months prior to C1D1 (including history of transient ischemic attack, cerebral stroke, brain trauma with disturbance of consciousness requiring hospitalization);
- •- Presence of active heart diseases within 6 months prior to C1D1, including severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug therapy;
- •- Any other malignant tumor within 5 years prior to C1D1 (except carcinoma in situ that has been completely relieved and the malignant tumor that is judged by investigators as slowly progressive);
- •- Active HBV, HCV infection (HBV virus?104copies/mL, HCVviru ?103copies/mL);
- •- History of immunodeficiency (including positive HIV test, or having other acquired or congenital immunodeficiency disease) or history of organ transplantation;
- •- Unwillingness to take effective contraceptive measures throughout the study treatment period and within 30 days after the last dose;
- •- Presence of concomitant diseases (e.g., poorly controlled hypertension, serious diabetes, neurological or psychological disorders, etc.) or any other conditions that seriously endanger patient’s safety, may confuse the study results or affect completion of the study, according to investigator’s judgement.
研究者
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