Actively Recruiting
Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer
Led by Tianjin Medical University Second Hospital · Updated on 2025-11-18
35
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy of nephron-sparing treatment combining Tislelizumab and Nab-Paclitaxel for HER-2 expressing renal pelvic cancer (RPC) . Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo evaluation. Patients who achieve all of the following criteria of "well response and tolerance" will receive further maintenance treatment: (1)The patient achieves a complete response (CR) or partial response (PR) according to the RECIST 1.1 criteria, indicating that the tumor is well-controlled. (2) If the patient has residual lesions, it should be confirmed by the clinical physician that these lesions can be eliminated through laser ablation via ureteroscopy. (3)The patient has not experienced any treatment-related adverse events (TRAEs) that warrant discontinuation of therapy during systemic treatment. (4)The patient is willing to undergo further maintenance therapy. If the patient meets all the criteria above, ureteroscopic biopsy should be performed. If residual lesions are detected under the ureteroscope, endoscopic intervention (e.g., laser ablation, cryoablation) should be carried out simultaneously to eliminate these residual lesions. Patients who meet the above criteria will proceed with no less than 2 cycles of maintenance systemic therapy (Tislelizumab + Nab-Paclitaxel). Patients who do not meet the criteria will be excluded from the study and are recommended to undergo salvage radical nephroureterectomy (RNU) as soon as possible. One-year Nephron-Sparing Survival (1 year-NSS): Defined as the absence of surgical indications for nephrectomy due to progression or recurrence of upper urinary tract urothelial carcinoma, distant metastasis caused by the primary upper urinary tract tumor, or death from any cause within 1 year from the initiation of treatment. Treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.
CONDITIONS
Official Title
Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged no less than 18 years old
- Suitable and planned to undergo laser ablation of renal pelvic tumors via ureteroscopy
- Tumor located in the renal pelvis, diagnosed as upper tract urothelial carcinoma by biopsy, cytology, or imaging, with no lymph node or distant metastasis, clinical stage T1-2N0M0
- Maximum tumor diameter less than 3 cm
- Expected survival time more than 12 weeks
- ECOG Performance Status of 0-2
- Agree to provide blood, urine, and tissue samples for testing
- Organ function meeting specified hematological, liver, and renal requirements
- Willing to join the study and able to comply with the protocol
You will not qualify if you...
- Presence of concurrent primary malignancies in other sites, except stable treated malignancies
- Confirmed bilateral upper tract urothelial carcinoma
- Presence of urothelial carcinoma in ureter or bladder, except completely resected non-muscle-invasive bladder cancer
- Received live attenuated vaccine within 4 weeks before treatment or planned during study
- Active, known, or suspected autoimmune disease
- Known primary immunodeficiency
- History of allogeneic organ or hematopoietic stem cell transplantation
- Pregnant or breastfeeding females
- Untreated acute or chronic active Hepatitis B or C infection
- Immunosuppressive medication within 4 weeks before treatment, except certain steroids
- Known or suspected allergy to Tislelizumab or Nab-Paclitaxel
- Active tuberculosis
- Previous treatment with PD-1/PD-L1/CTLA-4 checkpoint inhibitors or other immunotherapies
- Participation in another clinical study
- Fertile men or women without effective contraception
- Uncontrolled illnesses including HIV infection, severe infections, severe psychiatric or neurological disorders, unstable respiratory, cardiovascular, liver or kidney disease, uncontrolled hypertension, active hemorrhage, thrombotic disease, or renal failure requiring dialysis
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Hospital of Tianjin Medical University
Tianjin, Outside U.S., China, 300211
Actively Recruiting
Research Team
H
Hailong Hu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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