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

Last updated: June 9, 2022
Sponsor: Tianjin Medical University Second Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Bladder Cancer

Urothelial Cancer

Treatment

N/A

Clinical Study ID

NCT05418309
TRUCE-22
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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-invasiveurothelial 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 ofpathological specimens are diagnosed as above, meanwhile, the tumor has to bediagnosed 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, tumormutation 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 aspartateaminotransferase <=2.5 ULN;
  1. The subjects volunteered to join the study, signed informed consent, and had goodcompliance with follow-up;

Exclusion

Exclusion Criteria:

  1. Receive live attenuated vaccine within 4 weeks before treatment or during the studyperiod;
  2. Active, known or suspected autoimmune diseases;
  3. History of primary immunodeficiency;
  4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stemcell transplantation;
  5. Pregnant or lactating female patients;
  6. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under thecondition of monitoring the virus copy number of patients receiving antiviraltreatment, doctors can judge whether they are in line with the patients' individualconditions;
  7. Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment,excluding nasal and inhaled corticosteroids or physiological doses of systemicsteroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids withthe 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 takereliable 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

Study Design

Total Participants: 63
Study Start date:
December 27, 2021
Estimated Completion Date:
July 31, 2024

Connect with a study center

  • Tianjin Medical University Second Hospital

    Tianjin, Tianjin 300211
    China

    Active - Recruiting

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