Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Second Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females aged no less than 18 years old;
Suitable and planned to undergo laser ablation of renal pelvic tumors via ureteroscopy;
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.
Expected survival time of more than 12 weeks;
Disqualifiers
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.
Confirmed bilateral upper tract urothelial carcinoma (UTUC).
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).
Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;
Trial design
Design model
Single group
Treatments tested in this trial
Nab-paclitaxel
DrugNab-Paclitaxel 125 mg/m2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles before evaluation, then on Day 1 every 3 weeks for maintenance therapy after evaluation (only for patients who achieved the criteria of "well response and tolerance").
Tislelizumab
DrugTislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles before evaluation, then on Day 1 every 3 weeks for 3-6 cycles as maintenance therapy after evaluation (only for patients achieved the criteria of "well response and tolerance").
endoscopic intervention
Procedure/SurgeryPatients who achieved the criteria of "well response and tolerance", but with residual lesions will receive endoscopic intervention (e.g., laser ablation, cryoablation) via ureteroscopy.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Arm 1Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
One-year Nephron-Sparing Survival (1-year-NSS)
This is 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. Kaplan-Meier curves will be constructed to provide descriptive information on nephron-sparing survival.
Time frame
up to 1 year from the initiation of treatment.Secondary outcomes
1
Treatment-related adverse events (TRAEs)
Treatment-related adverse events (TRAEs) ,defined as adverse events occurring from the start of treatment (C1D1) to 90 days after the completion of the last dose, including type, incidence rate, and severity grading (assessed according to the NCI-CTCAE V5.0 criteria)
Time frame
From treatment initiation to 90 days after the last cycle of treatment.2
Clinical Complete Response (cCR)
Defined as the achievement of a complete response (CR) based on RECIST 1.1 criteria in radiological assessment following neoadjuvant therapy, negative results on urinary cytology, absence of residual tumor in the upper urinary tract as demonstrated by ureteroscopy, and no residual tumor in the specimen from ureteroscopic biopsy.
Time frame
At the time of ureteroscopic biopsy (for efficacy evaluation) completed (within 14 weeks of the treatment initiated)3
Objective Response (OR)
Defined as the achievement of partial response (PR) or complete response (CR) based on RECIST 1.1 criteria, as assessed by imaging studies at efficacy evaluation.
Time frame
After completion of the last cycle (cycle 2 or cycle 3，each cycle is 21 days） of therapy.4
Events-Free Survival (EFS)
Defined as the time from treatment initiated to the first occurrence of delayed surgical disease progression, local tumor recurrence (including recurrence in the upper urinary tract and bladder, excluding non-muscle-invasive bladder cancer that can be resected by TURBT), distant metastasis, or death from any cause. The study will record the 1-, 2-, and 5-year EFS rates for the target population. Kaplan-Meier methods will be used to estimate the median EFS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on EFS
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov