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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Second Hospital of Tianjin Medical University
  Tianjin, Outside U.S., China Recruiting

Study contacts

• Study coordinator: Hailong Hu
• Email: Huhailong@tmu.edu.cn
• Phone: +86 13662096232

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  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.

  Recruiting Phase 2 Tianjin Medical University Second Hospital · Tianjin, Outside U.S. · NCT07125547

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

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

  Recruiting Phase 2 Tianjin Medical University Second Hospital · Tianjin, Outside U.S. · NCT07233252

• Adding tislelizumab with or without the probiotic Probio-M9 to pre-surgery chemoradiation for pMMR/MSS locally advanced rectal cancer.

  This will see if adding the PD-1 drug tislelizumab, with or without the probiotic Probio-M9, to standard pre-surgery chemoradiation helps adults with pMMR/MSS locally advanced rectal cancer.

  Recruiting Phase 2 Seventh Medical Center of PLA General Hospital · Beijing, Beijing Municipality · NCT07458529

• Tislelizumab with Anlotinib and Nab-Paclitaxel before surgery for resectable NSCLC

  A group of adults with stage II–III non-small cell lung cancer is given tislelizumab plus anlotinib and nab-paclitaxel before surgery to see if the treatment helps shrink tumors and is safe.

  Recruiting Phase 2 Qilu Hospital of Shandong University · Jinan, Shandong · NCT07089199

• Tislelizumab plus FLOT given before surgery for operable esophagus or stomach adenocarcinoma

  This trial tests whether adding the immunotherapy drug tislelizumab to FLOT chemotherapy given before surgery helps people with locally advanced, resectable esophagus or stomach adenocarcinoma shrink tumors and better tolerate treatment.

  Recruiting at 2 sites Phase 1 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Frankfurt and 3 other locations · NCT07059299

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.