Condition: Bladder Cancer · Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
This description comes directly from the study's public registry record.
Wenlong Zhong, Ph.D · 020-81338949 · zhongwlong3@mail.sysu.edu.cn
Always discuss trial participation with your own doctor first.
| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong, China | Recruiting |
| Sun Yat-sen Memorial Hospital | Guangzhou, Guangdong, China | Recruiting |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
| Zhujiang Hospital of Southern Medical University | Guangzhou, Guangdong, China | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Recruiting |
| Hunan Cancer Hospital | Changsha, Hunan, China | Recruiting |
| Xiangya Hospital, Central South University | Changsha, Hunan, China | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06364956