Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Tislelizumab and Hypofractionated Radiotherapy plus Nab-Paclitaxel/Gemcitabine as Conversion Therapy for BRPC/LAPC: A Phase II Trial with Dynamic Biomarker Monitoring.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Ni Jiayao, Sun Yi, Cheng Hao, Bai Xinyuan, Tong Fan, Zhang Xing, Wang Xiaoxuan, Mao Liang, Li Gang, Shen Shanshan, Kong Weiwei, He Jian, Li Aimei, Chen Jun, Tang Min, Chen Bozhu, Li Qi, Gu Qing, Lu Zhongyu, Chen Dongsheng, Sha Huizi, Liu Baorui, Qiu Yudong, Du Juan
Аннотация
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 (95% CI, 20.1-NR). Grade ≥3 adverse events (AE) occurred in 33/56 patients (58.9%). Dynamic biomarker exploration revealed that baseline IL6 level (>5 pg/mL) predicted better PFS. Moreover, circulating tumor DNA (ctDNA) status and clearance demonstrated superior survival.
CONCLUSIONS: The THAG regimen as preoperative therapy showed encouraging clinical activity with a manageable safety profile. Dynamic biomarker findings reveal potential for guiding precision treatment strategies with THAG.
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 (95% CI, 20.1-NR). Grade ≥3 adverse events (AE) occurred in 33/56 patients (58.9%). Dynamic biomarker exploration revealed that baseline IL6 level (>5 pg/mL) predicted better PFS. Moreover, circulating tumor DNA (ctDNA) status and clearance demonstrated superior survival.
CONCLUSIONS: The THAG regimen as preoperative therapy showed encouraging clinical activity with a manageable safety profile. Dynamic biomarker findings reveal potential for guiding precision treatment strategies with THAG.