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Muscle Invasive Bladder CancerPhase 2NCT04730219

Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Carcinoma

A Phase 2 study testing Tislelizumab and Nab paclitaxel in people with Muscle Invasive Bladder Cancer and Urothelial Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase II study to determine 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
What is being tested?
Tislelizumab and Nab paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
11 Jul 2020to Jul 2024
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
  • 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 N0 M0 disease by CT (or MRI). If the clinical stage is T2-4aN1-3M0, it must be judged by the investigator. If it is judged that radical surgery can still be performed, it can be included in the study.
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  • 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

  • Tianjin Medical University Second Hospital

    Tianjin, Tianjin Municipality, 300211

Other trials in China

About this study

Official title: An Open Label, Single-arm, Phase 2 Study of Perioperative Tislelizumab Combined With Nab-Paclitaxel Before Cystectomy or Complete TURBT for Patients With Muscle-invasive Urothelial Bladder Cancer.

This is a phase II study to determine 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 treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by standard radical cystectomy or complete TURBT.

Keywords
neoadjuvant treatment
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

    Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles

  • Nab paclitaxelDrug

    Nab paclitaxel 200mg will be administered on Day 2 every 3 weeks for 3 cycles

Study groups in NCT04730219
Study groupRoleWhat they receive
Tislelizumab and Nab PaclitaxelExperimentalTislelizumab 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; Drug: Nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Complete Response (cCR) rate

    defined as the absence of tumor residual confirmed by surgery (RC-PLND or complete TURBT), negative urine cytology and no evidence of lymph nodes or distant metastasis on imaging.

    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)

  1. 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)

  2. 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

  3. 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

  4. Disease-specific survival (DSS)

    DSS was documented from the date of initial treatment till the date of the disease-related death.

    Measured: up to 3 years

  5. 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.

  1. First posted29 Jan 2021
  2. Study start11 Jul 2020
  3. Primary completionFeb 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04730219
Sponsor's protocol ID
TRUCE-01
Status last verified
Nov 2022
First submitted
25 Jan 2021
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen H, Lin Y, Xue Z, Qie Y, Wu Z, Liu K, Huang S, Jia K, Yang S, Zhang Z, Li P, Li X, Liu L, Shen C, Hu H. Urinary protein semi-quantification in immunochemotherapy for bladder cancer: markers of clinical outcomes. Front Immunol. 2026 Aug 10;17:1929760. doi: 10.3389/fimmu.2026.1929760. eCollection 2026.

    PubMed 42639047

  • Shen C, Chai W, Han J, Zhang Z, Liu X, Yang S, Wang Y, Wang D, Wan F, Fan Z, Hu H. Identification and validation of a dysregulated TME-related gene signature for predicting prognosis, and immunological properties in bladder cancer. Front Immunol. 2023 Oct 27;14:1213947. doi: 10.3389/fimmu.2023.1213947. eCollection 2023.

    PubMed 37965307

  • Shen C, Bi Y, Chai W, Zhang Z, Yang S, Liu Y, Wu Z, Peng F, Fan Z, Hu H. Construction and validation of a metabolism-associated gene signature for predicting the prognosis, immune landscape, and drug sensitivity in bladder cancer. BMC Med Genomics. 2023 Oct 26;16(1):264. doi: 10.1186/s12920-023-01678-6.

    PubMed 37880682

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and Nab paclitaxel in people with Muscle Invasive Bladder Cancer and 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 13 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 30 Nov 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Complete Response (cCR) 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?

On the ClinicalTrials.gov record for NCT04730219, which also lists 3 linked publications.

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 30 Nov 2022.

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