Muscle Invasive Bladder Cancer Urothelial CarcinomaPhase 2NCT05328336
Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Cancer: A Multicenter Study
A Phase 2 study testing Tislelizumab Nab paclitaxel in people with Muscle Invasive Bladder Cancer Urothelial Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This is a single-arm, open-label, multicenter clinical trial to investigate the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or complete TURBT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer Urothelial Carcinoma
- What is being tested?
- Tislelizumab Nab paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2021to Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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;
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211
Hailong Hu, MD,PhD, +86-13662096232, hhllove2004@163.com
About this study
Official title: 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
This is a single-arm, open-label, multicenter clinical trial to investigate the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or complete TURBT. Patients will receive perioperative treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by radical cystectomy or complete TURBT.
- Being tested
- Tislelizumab Nab paclitaxel
- Keywords
- neoadjuvant treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab Nab paclitaxelDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tislelizumab and Nab Paclitaxel | Experimental | 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. Receives: Drug: Tislelizumab Nab paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response (CR) rate
defined as the percentage of participants having CR. CR is defined as absence of viable tumor in examined tissue
Measured: At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
Secondary outcomes (5)
Number of subjects that reach pathological downstaging to <pT2
defined as pT0-T1N0M0 at the time of cystectomy or cTURBT
Measured: 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)
defined as the proportion of patients who have a partial or complete response to therapy
Measured: 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)
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.
Measured: up to 3 years
Overall Survival (OS)
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.
Measured: up to 3 years
Number of adverse events and severity by grade (CTCAE)
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).
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start11 Nov 2021
- Primary completionJul 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Cancer Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328336
- Sponsor's protocol ID
- TRUCE-11
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05328336
- Acronym / sponsor ID
- TRUCE-11
- Keywords
- neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, open-label, multicenter clinical trial to investigate the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or complete TURBT. Patients will receive perioperative treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by radical cystectomy or complete TURBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Tislelizumab and Nab Paclitaxel | Experimental | Drug: Tislelizumab Nab paclitaxelExperimental: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab Nab paclitaxelDrug: 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 | Drug | Experimental: Tislelizumab and Nab Paclitaxel |
Primary outcome
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
5 secondary outcomes
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)
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)
Event-free survival (EFS)
Time frame: up to 3 years
Overall Survival (OS)
Time frame: up to 3 years
Number of adverse events and severity by grade (CTCAE)
Time frame: up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab Nab paclitaxel in people with Muscle Invasive Bladder Cancer Urothelial Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hailong Hu, MD,PhD (+86-13662096232, hhllove2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.