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/AClinical Study ID
NCT05418309
TRUCE-22
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing and able to provide written informed consent;
- Ability to comply with the protocol;
- Age ≥ 18 years;
- 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);
- 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;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
- Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumormutation load, IHC, detection of DNA and RNA, etc;)
- 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;
- The subjects volunteered to join the study, signed informed consent, and had goodcompliance with follow-up;
Exclusion
Exclusion Criteria:
- Receive live attenuated vaccine within 4 weeks before treatment or during the studyperiod;
- Active, known or suspected autoimmune diseases;
- History of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stemcell transplantation;
- Pregnant or lactating female patients;
- 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;
- 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);
- Known or suspected allergy to tislelizumab and albumin paclitaxel;
- Have a clear history of active tuberculosis;
- Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past;
- Participating in other clinical researchers;
- Men with reproductive capacity or women who are likely to become pregnant do not takereliable contraceptive measures;
- 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
ChinaActive - Recruiting

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