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Status unknownNCT04730232Updated Oct 29, 2021

Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

A Phase 2 interventional study of Tislelizumab and Nab-paclitaxel in High-Risk and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Tianjin Medical University Second Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.

Sponsored by Tianjin Medical University Second Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase II study to determine the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as treatment for patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.

02

Conditions studied

  • High-Risk
  • Non-Muscle Invasive Bladder Urothelial Carcinoma

Keywords

  • Tislelizumab
  • Nab-Paclitaxel
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 63 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Tianjin Medical University Second Hospital is the lead sponsor of 57 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Willing and able to provide written informed consent;
  2. Ability to comply with the protocol;
  3. Age ≥ 18 years;
  4. High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:

    a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);

  5. Multi-point biopsy of bladder shows there are more than 2 section and over 3 points of pathological specimens are diagnosed as above, meanwhile, the tumor has to be diagnosed as not completely resectable by at least 2 senior urologist;
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
  7. Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
  8. Organ function level must meet the following requirements:

    • Hematological indexes: neutrophil count >= 1.5x10\^9/L, platelet count >= 80x10\^9/L, hemoglobin >= 6.0 g/dl (can be maintained by blood transfusion);
    • Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=2.5 ULN;
  9. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;

Exclusion criteria

Exclusion Criteria:

  1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
  2. Active, known or suspected autoimmune diseases;
  3. History of primary immunodeficiency;
  4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  5. Pregnant or lactating female patients;
  6. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
  7. Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose);
  8. Known or suspected allergy to tislelizumab and albumin paclitaxel;
  9. Have a clear history of active tuberculosis;
  10. Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past;
  11. Participating in other clinical researchers;
  12. Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
  13. Uncontrolled concurrent diseases, including but not limited to:

    • HIV infected (HIV antibody positive);
    • Severe infection in active stage or poorly controlled;
    • Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]);
    • Patients with active bleeding or new thrombotic disease.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (estimated)

Study arms

  • 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 or 4 cycles followed by transurethral resection biopsy.

    Drug: Tislelizumab · Drug: Nab-paclitaxel

Interventions

  • DrugTislelizumab

    Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles.

    Also known as: BGB-A317

  • DrugNab-paclitaxel

    Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.

06

What researchers measure

Primary outcomes

  1. Complete Response (CR) Rate for tilelizumab combined with nab-paclitaxel

    Time frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of tislelizumab)

Secondary outcomes

  1. Cystectomy-Free Survival (CFS)

    defined from D1 of treatment until cystectomy.

    Time frame: up to 3 years

  2. Duration of Response (DOR)

    Time frame: up to 3 years

  3. 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).

    Time frame: 12 weeks of treatment plus 30 days for toxicity followup

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Second Hospital
    Tianjin, Tianjin 300211, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04730232
Lead sponsor
Tianjin Medical University Second Hospital
Responsible party
Sponsor
First posted
Jan 29, 2021
Start date
Dec 27, 2020
Primary completion
Feb 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Oct 29, 2021

Study contacts

Hailong Hu, MD,PhD
Contact
hhllove2004@163.com
+86-13662096232
Hailong Hu, MD,PhD
principal investigator · Tianjin Medical University Second Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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