Neoadjuvant tislelizumab plus nab‑paclitaxel before radical nephroureterectomy for upper tract urothelial carcinoma

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)

This will test whether giving the PD‑1 drug tislelizumab together with nab‑paclitaxel before surgery helps people with non‑metastatic upper tract urothelial carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (Academic / other)
• Drugs / interventions: Tislelizumab, prednisone
• Locations: 1 site (Tianjin, Outside U.S.)
• Trial ID: NCT07126119 on ClinicalTrials.gov

What this trial studies

This is an open‑label, single‑arm Phase II study at a single center where enrolled patients receive 2–3 cycles of tislelizumab combined with nab‑paclitaxel every three weeks prior to planned radical nephroureterectomy (RNU). After neoadjuvant treatment, surgical specimens from RNU will be examined to determine pathological response rates. Treatment‑related adverse events will be recorded and graded using CTCAE v5.0. The trial focuses on patients with non‑metastatic, high‑risk upper tract urothelial carcinoma confirmed by biopsy and imaging.

Who should consider this trial

Good fit: Adults (≥18) with biopsy‑confirmed, high‑risk non‑metastatic upper tract urothelial carcinoma who are fit for radical nephroureterectomy and have ECOG performance status 0–2 are ideal candidates.

Not a fit: Patients with metastatic disease, those unfit for major surgery, with inadequate organ function, or with non‑urothelial predominant tumors are unlikely to benefit from this neoadjuvant approach.

Why it matters

Potential benefit: If successful, this approach could increase tumor clearance before surgery and raise the rate of complete pathological responses, potentially improving long‑term outcomes.

How similar studies have performed: Neoadjuvant PD‑1/PD‑L1 therapies combined with chemotherapy have shown encouraging pathological response rates in muscle‑invasive bladder cancer, but data specific to upper tract urothelial carcinoma remain limited.

Eligibility criteria

Inclusion Criteria:

1. Males or females aged no less than 18 years old;
2. UTUC 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); High risk disease confirmed in accordance with the EAU guidelines.
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 RNU.
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, HER-2, 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.

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 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

Conditions Upper Tract Urothelial Carcinoma; Neoadjuvant Therapy; PD-1 Inhibitor; Nab-paclitaxel