A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT06364904
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib — DRUG
    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.
  • Tislelizumab, Cisplatin, Gemcitabine — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 15, 2024
Start date
Oct 31, 2025
Status verified
Feb 2025
Primary completion
Apr 15, 2027
Completion
Apr 15, 2029

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Gemcitabine plus Cisplatin
    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.
  • Experimental: Gemcitabine, Cisplatin plus Trilaciclib
    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.

Primary Outcome Measure

Percentage of Participants With Progression-Free Survival(PFS) [ Time Frame: 24 months ]

Central Contacts

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