- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05328336
Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Cancer: A Multicenter Study
A Single-arm, Multicenter, Open Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With Nab-Paclitaxel for the Perioperative Treatment of Muscle-invasive Bladder Cancer
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hailong Hu, MD,PhD
- Phone Number: +86-13662096232
- Email: hhllove2004@163.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300211
- Recruiting
- ianjin Medical University Second Hospital
-
Contact:
- Hailong Hu, MD,PhD
- Phone Number: +86-13662096232
- Email: hhllove2004@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Willing and able to provide written informed consent.
- Ability to comply with the protocol.
- Age ≥ 18 years.
- Suitable and planned for complete transurethral resection of bladder tumor or radical cystectomy
- At least one measurable lesion meeting RECISTv1.1 criteria prior to transurethral bladder tumor electrosurgery (MR/CT long diameter of ≥10 mm or short diameter of ≥15 mm of enlarged lymph node required for this measurable lesion according to RECISTv1.1)
- Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) urothelial cell pattern.
- Clinical stage T2-T4a NxM0 disease by CT (or MRI).
- Expected survival time is greater than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2.
- Agree to provide tissue examination specimens (used to detect PD-L1 expression, tumor mutation burden, etc.)
The organ function level must meet the following requirements:
- Hematological indicators: absolute neutrophil count ≥1.5×10^9/ L, platelet count ≥80×10^9/L, hemoglobin ≥6.0 g/dL (can be maintained by symptomatic treatment);
Liver function: total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase
≤ 2.5 times the upper limit of normal value, if there is intrahepatic transaminase ≤ 5 times the upper limit of normal value;
- Renal function: creatinine ≤ 2 times the upper limit of normal, and creatinine clearance ≥ 30 ml/min;
Exclusion Criteria:
- Receive live attenuated vaccines within 4 weeks before treatment or plan to receive live attenuated vaccines during the study period.
- Active, known or suspected autoimmune diseases.
- Known history of primary immunodeficiency.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Female patients who are pregnant or breastfeeding.
- Untreated acute or chronic active hepatitis B or C infection. In the case of patients receiving antiviral therapy, the doctor will judge whether they are eligible for enrollment according to the individual conditions of the patient while monitoring the virus copy number.
- Have used immunosuppressive drugs in the past 4 weeks before starting treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (that is, prednisolone or equivalent physiological doses of no more than 10 mg/day) Other corticosteroids).
- Those who are known or suspected to be allergic to tislelizumab and nab paclitaxel.
- Have a clear history of active tuberculosis.
- Have received PD-1/PD-L1/CTLA-4 antibody or other immunotherapy in the past.
- Those who are participating in other clinical research.
- Reproductive men or women who are likely to become pregnant have not taken reliable contraceptive measures.
Uncontrolled concurrent diseases include but are not limited to:
- HIV-infected persons (HIV antibody positive).
- Serious infections that are active or poorly clinically controlled.
- There are serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [ie refers to After drug treatment, it is still greater than or equal to CTCAE Grade 2 hypertension]) evidence.
- Active bleeding or new thrombotic disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Tislelizumab and Nab Paclitaxel
Experimental: Tislelizumab and Nab Paclitaxel Tislelizumab 200mg IV on day 1 in combination with nab paclitaxel 200mg IV on day 2 every 3 weeks for 3 cycles followed by surgery.
|
Drug: Tislelizumab Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles Other Names: • BGB-A317 Drug: Nab paclitaxel Nab paclitaxel 200mg will |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete response (CR) rate
Time Frame: At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
|
defined as the percentage of participants having CR.
CR is defined as absence of viable tumor in examined tissue
|
At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects that reach pathological downstaging to <pT2
Time Frame: At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
|
defined as pT0-T1N0M0 at the time of cystectomy or cTURBT
|
At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
|
Objective response rate (ORR)
Time Frame: At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
|
defined as the proportion of patients who have a partial or complete response to therapy
|
At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
|
Event-free survival (EFS)
Time Frame: up to 3 years
|
defined from D1 of neoadjuvant treatment until progression (in those who progress prior to surgery) or until recurrence (post-surgery) or until death as a result of any cause.
|
up to 3 years
|
Overall Survival (OS)
Time Frame: up to 3 years
|
defined as the number of days from study entry to death.
Individuals who are alive at last contact will be censored on the date of last contact.
|
up to 3 years
|
Number of adverse events and severity by grade (CTCAE)
Time Frame: up to 1 years
|
Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).
|
up to 1 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- TRUCE-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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