A Trial of SHR3162 Combined With Apatinib Mesylate Tablet... | NCT04869488

NCT04869488

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Fluzoparib	Experimental	Drug: Fluzoparib
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets	Active Comparator	Drug: Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Fluzoparib Combined With Apatinib	Experimental	Drug: Fluzoparib Combined With Apatinib

Name	Type	Description	Arm Group Labels	Other Names
Fluzoparib	Drug	Fluzoparib Orally twice daily（Cohort 1、Cohort 4）	Fluzoparib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comprehensive response rate	Comprehensive remission rate means the proportion of objective remission or PSA remission evaluated by the investigator based on the RECIST v1.1 standard and the PCWG3 standard	up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Radiological progression-free survival (rPFS)	The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.	up to 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary participation and written informed consent;
Age ≥18 years old;
Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
It is confirmed by the central laboratory based on tumor tissue or ctDNA detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (Cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (Cohort 2);
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Has a life expectancy of ≥ 12 weeks.

Exclusion Criteria:

Past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma;
Subjects have used PARP inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past Treatment with amide or platinum-containing chemotherapeutics;
Severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future;
The subject has cancerous meningitis, or untreated central nervous system metastasis;
Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥500 IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number> upper limit of normal );
According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, family or society, etc. Factors that will affect the safety of subjects or the collection of data and samples.