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
310P - A study on the prediction of recurrence site of endometrial cancer using various machine learning techniques
Presenter: Wonkyo Shin
Session: Poster Display
Resources:
Abstract
311P - Circulating cytokines in the differential diagnosis of endometrial cancer
Presenter: Tatyana Abakumova
Session: Poster Display
Resources:
Abstract
312P - Molecular and genetic features of squamous cell carcinoma of vulvar cancer depending on HPV status
Presenter: Visola Navruzova
Session: Poster Display
Resources:
Abstract
313P - Efficacy and safety of oral metronomic chemotherapy in recurrent refractory advanced gynaecological cancer: Experience from regional cancer center of eastern India
Presenter: Ranti Ghosh
Session: Poster Display
Resources:
Abstract
314P - Perioperative outcomes in advanced epithelial ovarian cancer treated with neoadjuvant bevacizumab and chemotherapy: Real-world experience from an Indian cancer centre
Presenter: Upasana Palo
Session: Poster Display
Resources:
Abstract
315P - Real-world experience of niraparib as maintenance therapy in newly diagnosed advanced ovarian cancer: A single-center retrospective study
Presenter: Wenxin Liu
Session: Poster Display
Resources:
Abstract
316P - First evidence of olaparib maintenance therapy in patients with newly diagnosed BRCA wild-type ovarian cancer: A real-world multicenter study
Presenter: Jing Li
Session: Poster Display
Resources:
Abstract
317P - Attitudes of Israeli gynecologists towards risk reduction salpingo-oophorectomy at hysterectomy for benign conditions and the use of hormonal therapy
Presenter: wisam Assaf
Session: Poster Display
Resources:
Abstract
319P - Survival prediction for ovarian cancer patients from Taiwan cancer registry data
Presenter: Tzu-Pin Lu
Session: Poster Display
Resources:
Abstract
320P - Treatment patterns and outcomes in Indian patients with advanced ovarian cancer: A single center experience
Presenter: Pushpendra Hirapara
Session: Poster Display
Resources:
Abstract