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
373P - Investigating the impact of treatment on geriatric patients with locally advanced head and neck squamous cell carcinoma
Presenter: Yen Ting Liu
Session: Poster Display
Resources:
Abstract
374P - Immunohistochemical evaluation of oral lichen planus: A prospective clinical study
Presenter: Saravanan Sampoornam Pape
Session: Poster Display
Resources:
Abstract
375P - Survival and prognostic factors of head and neck squamous cell carcinoma patients treated with either definitive CCRT or post operative CCRT with platinum-based chemotherapy in Rajavithi hospital, Thailand
Presenter: wanit samadee
Session: Poster Display
Resources:
Abstract
376P - Nutrition as an independent prognostic factor in locally advanced nasopharyngeal carcinoma: A retrospective cohort study and propensity score-matched analysis
Presenter: haizhen yi
Session: Poster Display
Resources:
Abstract
377P - Oropharyngeal squamous cell carcinomas in Indian population: P16 positivity and treatment outcomes following chemoradiotherapy
Presenter: Parth Verma
Session: Poster Display
Resources:
Abstract
378P - A real-world retrospective analysis of the efficacy of pembrolizumab combined with chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA HNSCC)
Presenter: zhu Liu
Session: Poster Display
Resources:
Abstract
379P - Nimotuzumab in combination with chemoradiation for patients with intermediate stage and locally advanced nasopharyngeal carcinoma: A retrospective comparative analysis using 5-year real-world survival data
Presenter: Andhika Rachman
Session: Poster Display
Resources:
Abstract
380P - An epidemiological analysis on the prevalence of oral cancer and its awareness among Irula tribes of South India
Presenter: Delfin Lovelina Francis
Session: Poster Display
Resources:
Abstract
381P - P16INK4 over-expression, early stages, keratinization, and surgical margin-free status are associated with better prognosis of oral squamous cell carcinoma (OSCC)
Presenter: Sumadi Lukman Anwar
Session: Poster Display
Resources:
Abstract
382P - Oral health disparities in privileged and underprivileged tribes of south India: A study of the prevalence of precancerous oral lesions
Presenter: Shanavas Palliyal
Session: Poster Display
Resources:
Abstract