the Efficacy and Safety of LDP in Patients With Urinary and Male Genital Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Penile Carcinoma
- Bladder Cancer
- Renal Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This trial is a single arm, open, multicenter, ? period clinical research. Three cohorts were included, 127 subjects were enrolled (Cohort 1: about 60 subjects with surgically suitable muscular-invasive bladder cancer; Cohort 2: about 40 subjects with advanced Non-clear Cell Renal Carcinoma; Cohort ...
This trial is a single arm, open, multicenter, ? period clinical research. Three cohorts were included, 127 subjects were enrolled (Cohort 1: about 60 subjects with surgically suitable muscular-invasive bladder cancer; Cohort 2: about 40 subjects with advanced Non-clear Cell Renal Carcinoma; Cohort 3: about 27 subjects with advanced penile carcinoma. After confirmation of inclusion, intravenous infusion of 10mg/kg human anti-PD-L1 monoclonal antibody injection (LDP) was given. The initial efficacy and safety of drugs in different tumor species in the cohort above will be observed.
Tracking Information
- NCT #
- NCT04718584
- Collaborators
- Fudan University
- Investigators
- Study Chair: Dingwei Ye Fudan University