Abstract 224P
Background
For locally advanced upper tract urothelial carcinoma (UTUC), no evidence proved the effectiveness and safety of neoadjuvant immunotherapy combined with chemotherapy. Toripalimab is an innovative anti-PD-1 monoclonal antibody approved in China across multiple cancer indications. The current trial aims to investigate the effectiveness and safety of neoadjuvant toripalimab combined with chemotherapy in patients with locally advanced UTUC.
Methods
This is a single-arm, phase 2 prospective trial. This trial aims to recruit 59 patients aged 18-75 years with cT2-4aN0-2M0 UTUC. Patients receive toripalimab (240mg p.o.) plus gemcitabine (1000mg/m2 on D1 and D8) and cisplatin (75mg/m2, D1) every 3 weeks for 3-4 cycles before radical nephroureterectomy (RU). Tumor response is determined according to RECIST 1.1 criteria. The primary outcome is pathologic complete response (pCR), which was defined as the absence of invasive cancer or in situ disease in the kidney and ureter after RU (ypT0N0M0).
Results
11 patients have been recruited in this trial. 9 patients had completed neoadjuvant combination therapy and successfully underwent RU. 3 out of the 9 patients (33.3%) achieved pCR after neoadjuvant combination therapy and 4 out of the 9 patients (44.4%) attained pathologic partial response. No treatment-related adverse event was observed among all patients.
Conclusions
Neoadjuvant toripalimab combined with chemotherapy appears be effective and well-tolerated for patients with locally advanced UTUC. This trial is continuing to recruit patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Y. Bao.
Funding
Shanghai Junshi Biosciences Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
485P - LDCT lung cancer screening of never-smokers meta-analysis subgroup analysis: Adenocarcinoma is the highly predictive histology identified in never-smokers
Presenter: Sai-Hong Ou
Session: Poster Display
Resources:
Abstract
486P - Fiscal feasibility and implications of integrating lung cancer screening into Hong Kong’s healthcare system
Presenter: Herbert Ho Fung Loong
Session: Poster Display
Resources:
Abstract
487P - Evaluating the performance of the USPSTF lung cancer screening guidelines in an Asian population of lung cancer patients
Presenter: Jian Wei Tan
Session: Poster Display
Resources:
Abstract
488P - Pulmonary ground glass opacity lesions: Immune ecosystem and its clinical relevances of early-stage lung adenocarcinoma
Presenter: Shensi Shen
Session: Poster Display
Resources:
Abstract
489TiP - BGB-LC-202 (NCT05577702): Phase II Umbrella study of tislelizumab (TIS) monotherapy and TIS-based immunotherapy combinations +/- chemotherapy (CT) as neoadjuvant treatment in Chinese patients (pts) with resectable stage II to IIIA non-small cell lung cancer (NSCLC)
Presenter: Wentao Yu
Session: Poster Display
Resources:
Abstract
491P - Furmonertinib as adjuvant therapy for elderly patients in resected EGFR-mutated non-small cell lung cancer: A double-center, real-world experience
Presenter: Ziheng Wu
Session: Poster Display
Resources:
Abstract
492P - Penpulimab-based combination neoadjuvant/adjuvant therapy for patients with resectable locally advanced non-small cell lung cancer: Preliminary results from a phase II study (ALTER-L043)
Presenter: Changli Wang
Session: Poster Display
Resources:
Abstract
493P - The prognostic value of 4L lymph node dissection in left-sided operable non-small cell lung cancer: A systematic review and meta-analysis
Presenter: Lei Peng
Session: Poster Display
Resources:
Abstract
495P - Intrinsic STING of CD8+T cells regulates self-metabolic reprogramming and exerts anti-tumor effects
Presenter: Qiuli Xu
Session: Poster Display
Resources:
Abstract
496P - Fruquintinib plus sintilimab in patients (pts) with advanced non-small cell lung cancer (NSCLC) with PD-L1-positive expression: A multicenter, single-arm phase II study
Presenter: Shun Lu
Session: Poster Display
Resources:
Abstract