A Phase 3 interventional study of Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib and Tislelizumab, Cisplatin, Gemcitabine in Bladder Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 3, Interventional, and Treatment
The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's planned enrollment of 210 is above the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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The participants must have well-functioning organ systems, as measured by the following screening laboratory values (obtained within ≤14 days before enrollment):
a. When screening for the following parameters, participants must not have used growth factor support within ≤14 days before sample collection: i. Neutrophil absolute count ≥ 1.5x10\^9/L ii. Platelets ≥ 90x10\^9/L iii. Hemoglobin ≥ 90g/L b. International normalized ratio or activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN) c. Calculated creatinine clearance ≥ 50 mL/min d. Serum total bilirubin ≤ 1.5×ULN (if Gilbert's syndrome or indirect bilirubin concentration indicates extrahepatic elevation, should be ≤ 3×ULN) e. AST, ALT, and alkaline phosphatase ≤ 2.5×ULN
Exclusion Criteria:
Prior systemic treatment for tumors, except:
During each 21 days study cycle(up to 6 cycles), all participants will receive: 1. Tislelizumab: Taken 1x time at d1 each cycle or until it is determined participant must stop the drug. 2. Gemcitabine: d1, d8 each cycle or until it is determined participant must stop the drug. 3. Cisplatin: d2 each cycle or until it is determined participant must stop the drug. Tislelizumab maintenance therapy:after chemoimmunotherapy, q3W until it is determined participant must stop the drug, or 2 years of treatment is completed.
Drug: Tislelizumab, Cisplatin, Gemcitabine
During each 21 days study cycle(up to 6 cycles), all participants will receive: 1. Tislelizumab: Taken 1x time at d1 each cycle or until it is determined participant must stop the drug. 2. Gemcitabine: d1, d8 each cycle or until it is determined participant must stop the drug. 3. Cisplatin: d2 each cycle or until it is determined participant must stop the drug. 4. Trilaciclib: d1, d2, d8 each cycle or until it is determined participant must stop the drug. Tislelizumab maintenance therapy:after chemoimmunotherapy, q3W until it is determined participant must stop the drug, or 2 years of treatment is completed.
Drug: Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib
Chemoimmunotherapy: 1. Tislelizumab: 200mg, 1x time at d1 each cycle 2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle 3. Cisplatin: 70 mg/m2, in d2 each cycle 4. Trilaciclib: 240mg/m2, d1, d2, d8 each cycle Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.
Chemoimmunotherapy: 1. Tislelizumab: 200mg, 1x time at d1 each cycle 2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle 3. Cisplatin: 70 mg/m2, in d2 each cycle Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.
Percentage of Participants With Progression-Free Survival(PFS)
Progression free survival was determined from start date of treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at the date of last disease evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Time frame: 24 months
Percentage of Participants With Incidence of Grade 3/4 Neutropenia
The proportion of participant with neutrophils with values \< 1\*10\^9/L during treatment.
Time frame: Within 28 days of initial dosing
Rate of ORR
The responses rate (PR+CR) in participants based on imaging \[CT scan of chest, abdomen, and pelvis (or MRI of abdomen and pelvis with CT chest without contrast when appropriate)\]
Time frame: 60 months
overall survival (OS)
OS was measured from the date the participant started study to death for any reason.
Time frame: 60 months
Safety and AE
Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event using the Medical Dictionary for Regulatory Activities (MedDRA) terms and graded per NCI-CTCAE v5.0. Number and Grade of patients who had a surgery-related adverse event (surgery-related AE) will be measured according to the Clavien-Dindo classification.
Time frame: 60 months
Disease Control Rate(DCR)
The responses rate (PR+CR+SD) in participants based on imaging \[CT scan of chest, abdomen, and pelvis (or MRI of abdomen and pelvis with CT chest without contrast when appropriate)\].
Time frame: 60 months
During Of Response(DOR)
During Of Response(DOR) was measured from the date from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause.
Time frame: 60 months
Biomarker Endpoint Analyses
Patients' biomarkers in urine, blood, and tumor tissues (include CPS, TPS, TMB, Ki67, etc.) will be detected with the treatment of the combination of Tislelizumab with Cisplatin and Gemcitabine, with or without Trilaciclib in untreated unresectable and metastatic urothelial.
Time frame: 60 months
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University