Actively Recruiting
Clinical Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-08-11
36
Participants Needed
8
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was conducted. This study will adopt a 3+3 design and include two predefined dose groups of palbociclib: 100mg QD, 125mg QD. Initially, Tislelizumab, 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination. The trial will use the first cycle (28 days) as the observation period for tolerability, observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy (30 patients) . This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer.
CONDITIONS
Official Title
Clinical Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide written informed consent
- Aged over 18 years at consent
- Diagnosed with urothelial bladder cancer with residual lesions after TURBT, staged cT2-T4aN0M0
- Histology showing at least 50% urothelial carcinoma if mixed type
- Presence of mutations or copy number variations activating cell cycle pathways
- ECOG Performance Status of 0 or 1
- Ineligible for Cisplatin treatment based on specific criteria
- Planning to have radical cystectomy after neoadjuvant therapy and willing to undergo surgery
- Availability of tumor tissue samples from TURBT and pathological reports
- Adequate organ function based on recent lab tests
- Female participants must not be pregnant and agree to use effective contraception during and after study
You will not qualify if you...
- Prior treatment with PD-1, PD-L1, PD-L2, CTLA4 or similar immunotherapies
- Systemic anticancer or immunomodulator therapies within 28 days before enrollment
- Prior radiotherapy for bladder cancer
- Recent chemotherapy without required treatment-free interval
- Recent major surgery or trauma within 28 days before enrollment
- Severe active infections requiring systemic treatment within 14 days
- Recent live vaccinations within 28 days
- Active autoimmune diseases needing systemic treatment
- Extensive chronic treatment with hormones or immunosuppressants
- History of significant electrolyte abnormalities or uncontrolled systemic diseases
- Untreated or unstable hepatitis B or active hepatitis C infection
- History of immunodeficiency or organ transplantation
- Known hypersensitivity to monoclonal antibodies or study drugs
- Unresolved toxicities from prior treatments impacting safety
- Medical conditions or substance abuse interfering with study participation
- Concurrent participation in another therapeutic clinical study
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Actively Recruiting
3
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
4
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
5
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
6
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
7
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
8
Xiangya Hospital, Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
W
Wenlong Zhong, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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