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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
PLD is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous use.
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.
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDisease control rate
Disease control rate defined as confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Time frame: at least 10 months
Objective response rate
Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria.
Time frame: at least 10 months
Progression free survival
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression.
Time frame: at least 10 months
Overall survival
Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause
Time frame: at least 10 months
Lili Wang
CONTACT
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