Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer

NCT ID: NCT07125547

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-05
• Study Completion Date: 2030-12-30

Brief Summary

This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy and safety of neoadjuvant Tislelizumab combined with Nab-Paclitaxel followed by distal ureterectomy for patients with non-metastatic ureteral cancer (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo distal ureterectomy (DU). The assessment of efficacy is based on the histology of specimen from DU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.

Conditions

Ureteral Cancer; Neoadjuvant Therapy; PD-1 Inhibitor; Kidney-sparing; Tislelizumab; Nab-paclitaxel

Study Design

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

Study Groups

Arm 1

Nab-Paclitaxel 125mg/m\^2 IV on day 1 in combination with Tislelizumab 200mg IV on day 1 every 3 weeks for 2-3 cycles and then followed by distal ureterectomy (Distal ureterectomy + Partial cystectomy +Psoas hitch procedure + Ureteral reimplantation into the bladder + Ipsilateral pelvic lymph node dissection).

Group Type: EXPERIMENTAL

PD-1 inhibitior

Intervention Type: DRUG

Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.

Nab-paclitaxel

Intervention Type: DRUG

Nab-Paclitaxel 125mg/m2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles

distal ureterectomy

Intervention Type: PROCEDURE

Distal ureterectomy (Distal ureterectomy + Partial cystectomy +Psoas hitch procedure + Ureteral reimplantation into the bladder + Ipsilateral pelvic lymph node dissection) will be conducted after neoadjuvant treatment.

Interventions

PD-1 inhibitior

Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.

Intervention Type: DRUG

Nab-paclitaxel

Nab-Paclitaxel 125mg/m2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles

Intervention Type: DRUG

distal ureterectomy

Distal ureterectomy (Distal ureterectomy + Partial cystectomy +Psoas hitch procedure + Ureteral reimplantation into the bladder + Ipsilateral pelvic lymph node dissection) will be conducted after neoadjuvant treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Males or females aged no less than 18 years old;

2. Ureteral cancer indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0).

3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component >50% in the specimen from ureteroscopic biopsy;

4. Suitable and planned to receive distal ureterectomy (including distal ureterectomy + partial cystectomy + ipsilateral pelvic lymph node dissection + psoas hitch procedure + ureteral reimplantation into the bladder).

5. Expected survival time of more than 12 weeks;

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;

6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥6.0 g/dL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml/min, with the affected-side GFR >10 ml/min, excluding the presence of a non-functional kidney (low-level decreasing curve on dynamic renal ECT imaging) on the affected side.

8.Participants are willing to join the study and be able to sign and comply the protocol.

Exclusion Criteria

1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.

2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).

3. Presence of urothelial carcinoma in the renal pelvis or bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).

4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;

5. Active, known or suspected history of autoimmune disease;

6. Known history of primary immunodeficiency;

7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;

8. Pregnant or breastfeeding female patients;

9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;

10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg/day of prednisone or equivalent dose of other corticosteroids);

11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;

12. Active tuberculosis;

13. Previous treatment with PD-1/PD-L1/CTLA-4 immune checkpoint inhibitors or other immunotherapies;

14. Participation in another clinical study;

15. Fertile men or women without effective contraception;

16. Uncontrolled concurrent illness, including but not limited to:

(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension [i.e., hypertension of CTCAE grade 2 or higher despite treatment]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.

• 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

Locations

The Second Hospital of Tianjin Medical University

Tianjin, Outside U.S., China

Site Status: RECRUITING

Countries

China

Central Contacts

Hailong Hu, PhD

Role: CONTACT

Huhailong@tmu.edu.cn

+86 13662096232

Facility Contacts

Hailong Hu

Role: primary

Huhailong@tmu.edu.cn

13662096232

Other Identifiers

TRUCE-U01

Identifier Type: -

Identifier Source: org_study_id