Neoadjuvant tislelizumab plus nab‑paclitaxel before kidney‑sparing distal ureterectomy for ureteral cancer

Neoadjuvant Tislelizumab Combined With Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U01)

This will try giving people with non‑metastatic ureteral cancer two to three cycles of tislelizumab plus nab‑paclitaxel before a kidney‑sparing distal ureterectomy to see if tumor response improves and the treatment is tolerable.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (other)
• Drugs / interventions: Tislelizumab, prednisone
• Locations: 1 site (Tianjin, Outside U.S.)
• Trial ID: NCT07125547 on ClinicalTrials.gov

What this trial studies

This is an open‑label, single‑arm, single‑center phase II study testing neoadjuvant tislelizumab combined with nab‑paclitaxel in patients with non‑metastatic ureteral urothelial carcinoma. Enrolled participants receive 2–3 cycles of the combination every three weeks followed by planned distal ureterectomy with standard surgical steps. Efficacy will be determined primarily from the histology of the surgical specimen, and safety will be tracked as treatment‑related adverse events graded by CTCAE v5.0. Blood, urine, and tissue samples will be collected for biomarker analyses such as PD‑L1 expression and tumor mutation burden.

Who should consider this trial

Good fit: Ideal candidates are adults with biopsy‑proven non‑metastatic ureteral urothelial carcinoma (T1‑4 N0‑2 M0), ECOG 0–2, who are planned for distal ureterectomy and can provide required biospecimens.

Not a fit: Patients with distant metastatic disease, those unfit for surgery, or those with histologies other than urothelial carcinoma are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could shrink tumors before surgery and increase the chance of kidney‑sparing distal ureterectomy while providing information on safety and biomarkers.

How similar studies have performed: Neoadjuvant chemoimmunotherapy has shown promise in bladder and upper‑tract urothelial cancers, but prospective data specifically for ureteral tumors are limited.

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.

Where this trial is running

Tianjin, Outside U.S.

• The Second Hospital of Tianjin Medical University — Tianjin, Outside U.S., China (RECRUITING)

Study contacts

• Study coordinator: Hailong Hu, PhD

Conditions: Ureteral Cancer, Neoadjuvant Therapy, PD-1 Inhibitor, Kidney-sparing, Tislelizumab, Nab-paclitaxel