This is a multicenter, randomized, controlled phase II Study of evaluating the efficacy and safety of immunotherapy combined with probiotics compound (Biolosion) in patients with advanced urothelial carcinoma.
This multicenter, randomized phase II trial is designed to study the efficacy and safety of probiotics compound (Biolosion) Immunotherapy of the physician's choice (IPC) plus versus IPC in patients with advanced urothelial carcinoma (aUC). Pervious received platinum-based therapies, previous received Immune checkpoint inhibitors, and the treatment lines will stratify randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
222
Sun yat-sen university cancer center
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGProgression-free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from randomization to the first documented disease progression, as determined by RECIST v1.1, or death from any cause, whichever occurs first. Disease progression will be assessed by independent radiologic review. Patients without documented progression or death at the time of analysis will be censored at their last tumor assessment date.
Time frame: Within approximately 48 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death from any cause. Participants still alive at the time of analysis will be censored at the date of the last follow-up.
Time frame: Within approximately 48 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as determined by RECIST v1.1 criteria, based on radiologic assessment. Responses will be confirmed by at least one subsequent imaging assessment.
Time frame: Within approximately 48 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) for at least 6 weeks after treatment initiation, based on RECIST v1.1 criteria.
Time frame: Within approximately 48 months
Time to Response (TTR)
Time to Response (TTR) is defined as the time from randomization to the first occurrence of a confirmed objective response (CR or PR) as determined by RECIST v1.1 criteria.
Time frame: Within approximately 48 months
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1.2g/m2, IV, days 1, 8, q3w
2.5mg/kg, IV, q2w
1.25mg/kg, IV, days 1, 8, q3w
200mg, IV, q3w
240mg, IV, q3w
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time from the first documented objective response (CR or PR) to disease progression or death, whichever occurs first, based on RECIST v1.1 criteria.
Time frame: Within approximately 48 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The number of participants who experience treatment-related adverse events (AEs) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. AEs will be graded on a scale from Grade 1 (mild) to Grade 5 (death related to AE). The severity, frequency, and type of AEs will be recorded and summarized. The results will be presented as the total number and percentage of participants experiencing any treatment-related AE, as well as a breakdown by AE grade and type. Treatment-related AEs will be determined by the investigator's clinical judgment based on available data.
Time frame: Within approximately 48 months