Tian Yitong, Li Changxian, Jin Ke, Ma Ling, Zhang Jiaguang, Zhang Xinyi, You Wei, Shen Haoyang, Ding Yuting, Qian Hao, Li Xiangcheng, Chen Xiaofeng
Department of Oncology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Department of Oncology, The Fourth Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Cancer Sci. 2025 Jan;116(1):204-213. doi: 10.1111/cas.16376. Epub 2024 Nov 3.
The efficacy of combined chemotherapy and immunotherapy has previously been demonstrated in patients with biliary tract cancer. The aim of this study was to assess the efficacy and safety of camrelizumab in combination with gemcitabine and apatinib as a first- or second-line treatment for advanced programmed death-ligand 1 (PD-L1)-positive biliary tract cancer. This prospective, single-arm, and exploratory clinical trial aimed at recruiting 20 PD-L1-positive patients (tumor proportion score ≥1% or combined positive score ≥1) who met the inclusion criteria. Camrelizumab (200 mg) was administered in combination with gemcitabine (800 mg/m) and apatinib (250 mg). The primary endpoint was the objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. Fourteen patients were enrolled between September 2, 2020, and December 15, 2022. At the data cutoff on August 16, 2023, the median follow-up time was 11.4 months (interquartile range, 4.5-15.4), with one patient still undergoing treatment. Among the enrolled patients, six achieved a partial response, and four had stable disease. The ORR was 42.9% (95% confidence interval [CI], 17.7-71.1), and the DCR was 71.4% (95% CI, 41.9-91.6). The median PFS was 5.4 months (95% CI, 2.8-not reached), and the median OS was 13.5 months (95% CI, 5.7-not reached). The most frequent grade 3 or 4 treatment-related adverse event was neutropenia (n = 4, 29%). The combination of camrelizumab, gemcitabine, and apatinib showed promising efficacy and acceptable safety in patients with advanced PD-L1-positive biliary tract cancer.
联合化疗和免疫疗法的疗效先前已在胆管癌患者中得到证实。本研究的目的是评估卡瑞利珠单抗联合吉西他滨和阿帕替尼作为晚期程序性死亡配体1（PD-L1）阳性胆管癌一线或二线治疗的疗效和安全性。这项前瞻性、单臂探索性临床试验旨在招募20名符合纳入标准的PD-L1阳性患者（肿瘤比例评分≥1%或综合阳性评分≥1）。卡瑞利珠单抗（200mg）与吉西他滨（800mg/m）和阿帕替尼（250mg）联合给药。主要终点是客观缓解率（ORR），次要终点是无进展生存期（PFS）、总生存期（OS）、疾病控制率（DCR）和安全性。2020年9月2日至2022年12月15日期间共纳入14例患者。在2023年8月16日的数据截止时，中位随访时间为11.4个月（四分位间距，4.5-15.4），有1例患者仍在接受治疗。在纳入的患者中，6例达到部分缓解，4例疾病稳定。ORR为42.9%（95%置信区间[CI]，17.7-71.1），DCR为71.4%（95%CI，41.9-91.6）。中位PFS为5.4个月（95%CI，2.8-未达到），中位OS为13.5个月（95%CI，5.7-未达到）。最常见的3级或4级治疗相关不良事件是中性粒细胞减少（n=4，29%）。卡瑞利珠单抗、吉西他滨和阿帕替尼联合用药在晚期PD-L1阳性胆管癌患者中显示出有前景的疗效和可接受的安全性。
