Camrelizumab combined with gemcitabine and apatinib in treating advanced PD-L1-positive biliary tract cancers.

IF 5.7 2区 医学 Q1 Medicine
Cancer Science Pub Date : 2024-11-03 DOI:10.1111/cas.16376
Yitong Tian, Changxian Li, Ke Jin, Ling Ma, Jiaguang Zhang, Xinyi Zhang, Wei You, Haoyang Shen, Yuting Ding, Hao Qian, Xiangcheng Li, Xiaofeng Chen
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引用次数: 0

Abstract

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/m2) 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.

Camrelizumab 联合吉西他滨和阿帕替尼治疗晚期 PD-L1 阳性胆道癌。
化疗和免疫疗法联合治疗胆道癌的疗效已在胆道癌患者中得到证实。本研究旨在评估坎瑞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)阳性胆道癌一线或二线治疗的有效性和安全性。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%或合并阳性评分≥1)。康瑞珠单抗(200 毫克)与吉西他滨(800 毫克/平方米)和阿帕替尼(250 毫克)联用。主要终点是客观反应率(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。14 名患者于 2020 年 9 月 2 日至 2022 年 12 月 15 日期间入组。数据截止日期为2023年8月16日,中位随访时间为11.4个月(四分位间范围为4.5-15.4),其中一名患者仍在接受治疗。在入组患者中,6 人获得部分应答,4 人病情稳定。ORR为42.9%(95%置信区间[CI],17.7-71.1),DCR为71.4%(95%置信区间[CI],41.9-91.6)。中位 PFS 为 5.4 个月(95% CI,2.8-未达标),中位 OS 为 13.5 个月(95% CI,5.7-未达标)。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(4例,29%)。坎瑞珠单抗、吉西他滨和阿帕替尼联合疗法在晚期PD-L1阳性胆道癌患者中显示出良好的疗效和可接受的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Cancer Science
Cancer Science ONCOLOGY-
CiteScore
9.90
自引率
3.50%
发文量
406
审稿时长
17 weeks
期刊介绍: Cancer Science (formerly Japanese Journal of Cancer Research) is a monthly publication of the Japanese Cancer Association. First published in 1907, the Journal continues to publish original articles, editorials, and letters to the editor, describing original research in the fields of basic, translational and clinical cancer research. The Journal also accepts reports and case reports. Cancer Science aims to present highly significant and timely findings that have a significant clinical impact on oncologists or that may alter the disease concept of a tumor. The Journal will not publish case reports that describe a rare tumor or condition without new findings to be added to previous reports; combination of different tumors without new suggestive findings for oncological research; remarkable effect of already known treatments without suggestive data to explain the exceptional result. Review articles may also be published.
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