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
298P - Managing locally advanced cervical cancer: Insights from a tertiary care center and a 3-year follow-up on outcomes
Presenter: Ambedkar Yadala
Session: Poster Display
Resources:
Abstract
299P - Sexual dysfunction assessment in longterm survivors of carcinoma cervix using LENT SOMA scale
Presenter: Niharika Sethi
Session: Poster Display
Resources:
Abstract
300P - Assessing ovarian function in Vietnamese cervical cancer patients who underwent ovary transposition prior to pelvic radiation therapy
Presenter: Cuong Nguyen
Session: Poster Display
Resources:
Abstract
301P - Correlation between cervical cancer recurrence after radiation therapy and vaginal microbiome
Presenter: Xiaoxian Xu
Session: Poster Display
Resources:
Abstract
302P - Expression of ERCC4 gene and its correlation with clinical and pathological parameters in cervical cancer
Presenter: Himanshu Mishra
Session: Poster Display
Resources:
Abstract
303P - Prognostic value of body composition and systemic inflammatory markers in patients with locally advanced cervical cancer following chemoradiotherapy
Presenter: Hui Guo
Session: Poster Display
Resources:
Abstract
305P - A real-world multicenter cohort study of lenvatinib (LEN) plus pembrolizumab (PEM) in Japanese patients with endometrial cancer: Interim analysis of GOGO-EM4 study
Presenter: Yoshikazu Nagase
Session: Poster Display
Resources:
Abstract
306P - Adjuvant treatment and impact on relapse in stage IA uterine papillary serous and clear cell carcinomas: A single center retrospective study
Presenter: Sachin Khurana
Session: Poster Display
Resources:
Abstract
307P - Hormonal therapy vs combination chemotherapy in metastatic leiomyosarcomas: A systematic review
Presenter: Patricia Angel
Session: Poster Display
Resources:
Abstract
309P - Expression of estrogen receptor is a negative predictive biomarker for immunotherapy with lenvatinib plus pembrolizumab for advanced endometrial cancer with pMMR
Presenter: Hiroyuki Fujii
Session: Poster Display
Resources:
Abstract