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

NCT ID: NCT04730232

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-27
• Study Completion Date: 2024-07-31

Brief 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.

Conditions

High-Risk; Non-Muscle Invasive Bladder Urothelial Carcinoma

Keywords

Tislelizumab; Nab-Paclitaxel

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

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

Nab-paclitaxel

Intervention Type: DRUG

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

Interventions

Tislelizumab

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

Intervention Type: DRUG

Nab-paclitaxel

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

Intervention Type: DRUG

Other Intervention Names

BGB-A317

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Second Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hailong Hu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Second Hospital

Locations

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hailong Hu, MD,PhD

Role: CONTACT

Phone: +86-13662096232

Email: hhllove2004@163.com

Facility Contacts

Hailong Hu

Role: primary

Other Identifiers

Truce-02

Identifier Type: -

Identifier Source: org_study_id