Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China.
Gastric Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
BMC Cancer. 2023 Aug 7;23(1):729. doi: 10.1186/s12885-023-11188-4.
Biliary tract cancer (BTC) is a relatively rare but highly aggressive malignancy. However, there is currently no satisfactory second-line regimen for patients without specific genetic mutations. Nanoparticle albumin-bound paclitaxel, also known as nab-paclitaxel (Abraxane, Bristol Myers Squibb), has shown activity in patients with BTC. Studies investigating the immunogenic features of BTC suggested that checkpoint inhibition may lead to antitumor immune responses. In recent years, improved survival has been observed in patients treated with chemotherapy combined with immunotherapy across multiple cancer types, including BTC. This clinical trial aims to evaluate the efficacy and safety of second-line sintilimab in combination with nab-paclitaxel in advanced BTC patients.
The NapaSinti trial is a prospective, nonrandomized, open-label, phase 2 study conducted at a tertiary hospital in Chengdu, China. Eligible patients are those with histologically or cytologically confirmed locally advanced non-resectable or metastatic adenocarcinoma in the biliary tract (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer), aged between 18 and 75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who have experienced disease progression after prior gemcitabine- or fluorouracil-based chemotherapy and have not received taxane or immune checkpoint inhibitor treatment. Enrolled patients will receive intravenous administration of sintilimab 200 mg on day 1 and nab-paclitaxel 125 mg/m2 on days 1 and 8, every three weeks. The primary endpoint is the objective response rate (ORR), while the secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety. Exploratory objectives aim to identify biomarkers and molecular signatures for predicting response or prognosis. Using Simon's two-stage design, a total of 63 participants will be enrolled in the study. This trial was initiated in March 2022 in China.
The NapaSinti trial evaluates the efficacy and safety of second-line sintilimab plus nab-paclitaxel for advanced biliary tract cancer. Additionally, the trial provides an opportunity for translational research.
Chinese Clinical Trial Registry ChiCTR2100052118. Registered October 19, 2021.
胆道癌（BTC）是一种相对罕见但高度侵袭性的恶性肿瘤。然而，目前对于没有特定基因突变的患者，尚无令人满意的二线治疗方案。白蛋白结合型紫杉醇纳米粒，也称为nab-紫杉醇（Abraxane， Bristol Myers Squibb），已在 BTC 患者中显示出活性。研究表明，BTC 的免疫原性特征表明检查点抑制可能会引发抗肿瘤免疫反应。近年来，在包括 BTC 在内的多种癌症类型中，接受化疗联合免疫治疗的患者的生存率得到了提高。本临床试验旨在评估二线替雷利珠单抗联合 nab-紫杉醇在晚期 BTC 患者中的疗效和安全性。
NapaSinti 试验是在中国成都的一家三级医院进行的前瞻性、非随机、开放标签、II 期研究。符合条件的患者是那些组织学或细胞学证实为局部晚期不可切除或转移性胆道腺癌（包括肝内胆管癌、肝外胆管癌和胆囊癌），年龄在 18 至 75 岁之间，东部合作肿瘤组（ECOG）体能状态为 0 或 1，在接受吉西他滨或氟尿嘧啶为基础的化疗后疾病进展，且未接受紫杉烷类或免疫检查点抑制剂治疗的患者。入组患者将接受替雷利珠单抗 200mg 静脉输注，第 1 天；nab-紫杉醇 125mg/m2 静脉输注，第 1 天和第 8 天，每 3 周一次。主要终点是客观缓解率（ORR），次要终点包括总生存期（OS）、无进展生存期（PFS）和安全性。探索性目标旨在确定预测反应或预后的生物标志物和分子特征。采用 Simon 的两阶段设计，本研究共入组 63 例患者。本试验于 2022 年 3 月在中国启动。
NapaSinti 试验评估了二线替雷利珠单抗联合 nab-紫杉醇治疗晚期胆道癌的疗效和安全性。此外，该试验为转化研究提供了机会。
中国临床试验注册中心 ChiCTR2100052118。注册于 2021 年 10 月 19 日。
