Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and/or grade tumors, such as kidneys with potentially decreased renal function after RNU. Neoadjuvant therapy is a series of treatments administered preoperatively for UTUC, mainly chemotherapy, and in recent years, novel therapies of immunotherapy have emerged. Since conventional cisplatin neoadjuvant regimens also require high preoperative renal function, neoadjuvant therapy regimens such as immunotherapy provide more effective and feasible treatments for patients who are intolerant to current cisplatin chemotherapy regimens. The aim of this study was to explore the efficacy and safety of the combination of disitamab vedotin, a human epidermal growth factor receptor-2 (HER-2) targeted ADC, and tislelizumab, a humanised PD-1 ICIs, as neoadjuvant treatment for non-metastatic, high-risk, HER-2 expressing UTUC. In our study, patients enrolled will receive neoadjuvant tislelizumab plus disitamab-vedotin therapy followed by radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA) .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Patients enrolled will receive 3 cycles of tislelizumab 200 mg in combination with disitamab-vedotin (RC48) 2.0mg/kg intravenously.
The Second Hospital of Tianjin Medical University
Tianjin, China
RECRUITINGpathological complete response (pCR)
no residual tumor was detected in the specimen from RNU/DU by pathological examination
Time frame: 3 months
Treatment-related adverse events
Classified in accordance with CTCAE version 5.0
Time frame: From treatment initiation to the end of treatment at 90 days.
overall survival
Defined as the time from treatment initiated to death from any cause
Time frame: 5 years since treatment initiation.
recurrence-free survival
defined as the time from treatment initiated to the first occurrence of tumor recurrence (including in the upper urinary tract, bladder or metastasis).
Time frame: 5 years since treatment initiation.
imaging complete response
no target lesions found in imaging examination
Time frame: 3 months.
imaging partial response
More than 30% decrease in sum of diameters of target lesion in imaging examination
Time frame: 3 months.
imaging progressive disease
More than 20% increase in sum of diameters or appearance of new lesions in imaging examination
Time frame: 3 months.
imaging stable disease
Time frame: 3 months.
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