Nephron-sparing tislelizumab and nab-paclitaxel for renal pelvic cancer

Nephron-sparing Treatment Combining Tislelizumab and Nab-Paclitaxel for Renal Pelvic Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U03)

This study will try combining tislelizumab and nab‑paclitaxel to shrink HER‑2–expressing renal pelvic tumors in adults eligible for ureteroscopic laser ablation.

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: NCT07233252 on ClinicalTrials.gov

What this trial studies

This is an open‑label, single‑arm, phase II study at a single center testing a nephron‑sparing approach for HER‑2–expressing renal pelvic carcinoma. Participants receive 2–3 cycles of tislelizumab plus nab‑paclitaxel every three weeks, then are evaluated by RECIST 1.1 for tumor response. Patients with a complete or partial response whose remaining lesions can be removed by ureteroscopic laser ablation, and who have tolerated systemic therapy without treatment‑stopping adverse events, proceed to maintenance treatment and local ablation. Blood, urine, and tissue samples will be collected to test PD‑L1, HER‑2, tumor mutation burden, and other biomarkers.

Who should consider this trial

Good fit: Adults (≥18) with localized upper tract urothelial carcinoma of the renal pelvis (clinical T1‑2N0M0), tumor ≤3 cm, ECOG 0–2, HER‑2–expressing tumors, and planned ureteroscopic laser ablation are ideal candidates.

Not a fit: Patients with lymph node or distant metastasis, tumors larger than 3 cm, poor organ function, or who cannot tolerate immunotherapy/chemotherapy or ureteroscopy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could control the tumor while preserving kidney tissue and avoiding radical surgery.

How similar studies have performed: PD‑1 inhibitors combined with chemotherapy have shown benefit in urothelial cancers broadly, but applying this combination specifically to enable nephron‑sparing treatment in renal pelvic tumors is novel and not yet established.

Eligibility criteria

Inclusion Criteria:

1. Males or females aged no less than 18 years old;
2. Suitable and planned to undergo laser ablation of renal pelvic tumors via ureteroscopy;
3. The tumor is located in the renal pelvis, diagnosed as upper tract urothelial carcinoma based on ureteroscopic biopsy, urinary cytology, or imaging examinations (CT, MRI, or PET-CT), without lymph node metastasis or distant metastasis, with a clinical stage of T1-2N0M0. Additionally, requiring maximum tumor diameter is less than 3 cm.
4. Expected survival time of more than 12 weeks;
5. 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, 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 ureter 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 Renal Pelvic Carcinoma; Tislelizumab; PD-1 Inhibitor; Kidney-sparing; Nab-paclitaxel