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

Launched by TIANJIN MEDICAL UNIVERSITY SECOND HOSPITAL · Aug 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with ureteral cancer, which is a type of cancer in the tube that connects the kidney to the bladder. The trial is testing whether giving two medicines—Tislelizumab (an immune therapy that helps the body fight cancer) and Nab-Paclitaxel (a chemotherapy drug)—before surgery can help shrink the tumor and improve outcomes. After receiving 2 to 3 cycles of these medicines every three weeks, patients will have a surgery called distal ureterectomy, which aims to remove the affected part of the ureter while sparing the kidney.

Patients who might be eligible are adults diagnosed with ureteral cancer that has not spread to other parts of the body, confirmed by biopsy and imaging tests. They should be healthy enough to have surgery and meet certain blood and organ function requirements. People with other serious health issues, autoimmune diseases, or previous similar treatments may not qualify. If accepted, participants will receive the combination treatment, followed by surgery, and doctors will carefully monitor how well the treatment works and watch for any side effects. This study may offer a new kidney-sparing option for people with ureteral cancer, and is currently recruiting patients.

Gender

ALL

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.