the Efficacy and Safety of LDP in Patients With Urinary and Male Genital Tumors
NCT04718584 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127
Last updated 2021-01-22
Summary
This is a single-arm,open, multicenter, phase II clinical study of the efficacy and safety of human anti-PD-L1 monoclonal antibody Injection (LDP) in the treatment of urinary and male genital tumors.
Conditions
- Bladder Cancer
- Renal Carcinoma
- Advanced Penile Carcinoma
Interventions
- DRUG
-
Human Anti-PD-L1 Monoclonal Antibody Injection (LDP)
All participants will receive treatment with LDP 10mg/kg once every two weeks, every 2 weeks will be a cycle. In Cort 1, surgical treatment will be performed within 2 weeks after the end of 3 cycles of treatment.
Sponsors & Collaborators
-
Fudan University
collaborator OTHER -
Dragonboat Biopharmaceutical Company Limited
lead INDUSTRY
Principal Investigators
-
Dingwei Ye · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-11
- Primary Completion
- 2022-11-30
- Completion
- 2023-11-30
Countries
- China
Study Locations
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