Tislelizumab and Hypofractionated Radiotherapy plus Nab-Paclitaxel/Gemcitabine as Conversion Therapy for BRPC/LAPC: A Phase II Trial with Dynamic Biomarker Monitoring

作者：Jiayao Ni, Yi Sun, Hao Cheng, Xinyuan Bai, Fan Tong, Xing Zhang, Xiaoxuan Wang, Liang Mao, Gang Li, Shanshan Shen, Weiwei Kong, Jian He, Li AiMei, Jun Chen, Min Tang, Bozhu Chen, Qi Li, Qing Gu, Zhongyu Lu, Dongsheng Chen, Huizi Sha, Baorui Liu, Yudong Qiu, Juan Du · 发表于：Clinical Cancer Research · 年份：2025 · DOI：10.1158/1078-0432.ccr-25-2461 · 被引用次数：1 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Colorectal Cancer Treatments and Studies、Management of metastatic bone disease

PURPOSE: The optimal conversion treatment for patients with borderline resectable pancreatic cancer or locally advanced pancreatic cancer (BRPC/LAPC) remains unclear. In this study, we present the efficacy and safety results of a phase II trial evaluating tislelizumab combined with hypofractionated radiotherapy plus nab-paclitaxel/gemcitabine (THAG) in patients with BRPC/LAPC (ChiCTR2000032955, NCT05634564). PATIENTS AND METHODS: This phase II trial enrolled 56 patients with BRPC/LAPC (BRPC: 17, 30.4%; LAPC: 39, 69.6%). Participants received tislelizumab plus nab-paclitaxel/gemcitabine (AG) in 21-day cycles. Nonprogressing patients received concurrent radiotherapy during the third chemotherapy cycle. After four treatment cycles, a multidisciplinary team assessed eligibility for radical surgery. Dynamic biomolecular profiling was performed. RESULTS: Fifty-six eligible patients were enrolled. The objective response rate was 51.8% [95% confidence interval (CI), 38.0%-65.3%]. Median progression-free survival (mPFS) was 13.2 months (95% CI, 11.6-19.4 months), and median overall survival (mOS) was 21.3 months [95% CI, 18.8-not reached (NR)]. Among 30 patients who met criteria for surgical resectability, 22 patients (22/56, 39.3%) underwent radical resection, comprising nine patients with BRPC (9/17, 52.9%) and 13 patients with LAPC (13/39, 33.3%). The margin-negative resection rate reached 90.9% (95% CI, 70.8%-98.9%), and the mOS of patients who underwent surgery was 34.0 months (9...