New drug combo aims to save kidneys in pelvic cancer patients
NCT ID NCT07233252
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether a combination of tislelizumab (an immunotherapy) and nab-paclitaxel (a chemotherapy drug) can treat renal pelvic cancer while allowing patients to keep their kidney. About 35 adults with early-stage cancer will receive the drugs, and if the tumor shrinks enough, they may also get laser or freezing treatment to remove any remaining cancer. The main goal is to see if patients can avoid kidney removal for at least one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab and nab-paclitaxel
- What this could lead to
- If successful, this could offer a way to treat renal pelvic cancer without removing the kidney, preserving kidney function.
- What could go wrong
- This is a small, early-phase trial with only 35 participants, so results may not apply widely. The combination therapy may cause side effects, and not all patients will respond well.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Hospital of Tianjin Medical University
RECRUITINGTianjin, Outside U.S., 300211, China
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