NCT04101812

Pegylated Liposomal Doxorubicin, PD-1 in Treating Muscle Invasive Bladder Cancer

A Non-randomized, Prospective Clinical Study of Pegylated Liposomal Doxorubicin and PD-1 in the Second-line Treatment of Relapse or Metastatic Muscle Invasive Bladder Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Despite primary surgical management of muscle invasive bladder cancer (MIBC) with radical cystectomy and pelvic lymphnode dissection, up to 50% of patients will eventually develop tumours at distant sites, owing to pre-existing disseminated occult micrometastases. The first line treatment for relapse or metastatic MIBC is gemcitabine and cisplatin. After the failure of first line treatment, second line chemotherapy drugs can be chosen from doxorubicin, docetaxel, pemetrexed, etc. This non-randomized, prospective study aims to explore the efficacy and safety of PEGylated liposomal doxorubicin and PD-1 in second line treatment of MIBC.

Conditions

• Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin (PLD)	PLD is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous use.
DRUG	PD-1	PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands and PD-L1.

Timeline

• Start date: 2019-09-17
• Primary completion: 2020-05-31
• Completion: 2021-05-31
• First posted: 2019-09-24
• Last updated: 2019-09-26

Locations

1 site across 1 country: China