---
title: Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
nct_id: NCT04730232
overall_status: UNKNOWN
phase: PHASE2
sponsor: Tianjin Medical University Second Hospital
study_type: INTERVENTIONAL
primary_condition: High-Risk
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04730232.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04730232"
ct_last_update_post_date: 2021-10-29
last_seen_at: "2026-05-12T07:24:53.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

**Official Title:** An Open Label, Single-arm, Phase 2 Study of Tislelizumab Combined With Nab-Paclitaxel for Patients With High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

**NCT ID:** [NCT04730232](https://clinicaltrials.gov/study/NCT04730232)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 63
- **Lead Sponsor:** Tianjin Medical University Second Hospital
- **Conditions:** High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma
- **Start Date:** 2020-12-27
- **Completion Date:** 2024-07
- **CT.gov Last Update:** 2021-10-29

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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:

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.
```

## Arms

- **Tislelizumab and Nab-Paclitaxel** (EXPERIMENTAL) — 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.

## Interventions

- **Tislelizumab** (DRUG) — Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles.
- **Nab-paclitaxel** (DRUG) — Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.

## Primary Outcomes

- **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

- **Cystectomy-Free Survival (CFS)** _(time frame: up to 3 years)_
- **Duration of Response (DOR)** _(time frame: up to 3 years)_
- **Number of adverse events and severity by grade (CTCAE)** _(time frame: 12 weeks of treatment plus 30 days for toxicity followup)_

## Locations (1)

- Tianjin Medical University Second Hospital, Tianjin, Tianjin Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tianjin medical university second hospital|tianjin|tianjin municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04730232.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04730232*  
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