多中心II期研究：纳武利尤单抗联合卡瑞利珠单抗与单纯纳武利尤单抗作为晚期胃癌二线治疗的比较
Multi-center phase II study of nab-paclitaxel plus camrelizumab versus nab-paclitaxel alone as second-line treatment for advanced gastric cancer.
作者信息
Sun Li, Gong Zhimin, Wang Lei, Kuang Li, Huang Qiao, Pei Bo, Yuan Xianglin, Qiu Hong
机构信息
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
Department of Oncology, Xiangyang Central Hospital, Affiliated Hospital of HubeiUniversity of Arts and Science, Xiangyang 441021, China.
出版信息
Oncologist. 2025 Jul 4;30(7). doi: 10.1093/oncolo/oyaf189.
BACKGROUND
Nab-paclitaxel is a standard second-line treatment for advanced gastric cancer, but the role of PD-1 inhibitors remains uncertain. This multicenter, randomized phase II trial evaluated the efficacy of nab-paclitaxel plus camrelizumab (Cam-NP) versus nab-paclitaxel alone (NP) in patients with advanced gastric adenocarcinoma resistant to prior treatment.
METHODS
Patients were randomized to receive either Cam-NP or NP until disease progression, intolerable toxicity, or consent withdrawal. The primary endpoint was the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), and safety.
RESULTS
Sixty one patients were randomized, with 58 receiving treatments. At a median follow-up of 34.5 months, the Cam-NP group achieved a significantly higher ORR (33.3% vs. 10.7%; P = .039) and longer median PFS (5.62 vs. 4.21 months; P = .006). Median response duration also favored Cam-NP (4.64 vs. 2.96 months; P = .058). While the Cam-NP group showed a longer OS (9.8 vs. 7.2 months; P = .087), this was not statistically significant. The most common grade 3-4 adverse event was hematological toxicity.
CONCLUSIONS
Cam-NP significantly improved ORR and PFS compared to NP as a second-line treatment for advanced gastric adenocarcinoma. Larger studies and biomarker exploration are needed to validate these findings.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04294784, 03/02/2020.
背景
纳米白蛋白结合型紫杉醇是晚期胃癌的标准二线治疗药物，但PD-1抑制剂的作用仍不明确。这项多中心、随机II期试验评估了纳米白蛋白结合型紫杉醇联合卡瑞利珠单抗（Cam-NP）与单纯纳米白蛋白结合型紫杉醇（NP）用于先前治疗耐药的晚期胃腺癌患者的疗效。
方法
患者被随机分配接受Cam-NP或NP治疗，直至疾病进展、出现不可耐受的毒性或患者撤回同意书。主要终点为总缓解率（ORR），次要终点包括无进展生存期（PFS）、总生存期（OS）和安全性。
结果
61例患者被随机分组，58例接受了治疗。中位随访34.5个月时，Cam-NP组的ORR显著更高（33.3%对10.7%；P = 0.039），中位PFS更长（5.62对4.21个月；P = 0.006）。中位缓解持续时间也有利于Cam-NP组（4.64对2.96个月；P = 0.058）。虽然Cam-NP组的OS更长（9.8对7.2个月；P = 0.087），但差异无统计学意义。最常见的3-4级不良事件是血液学毒性。
结论
作为晚期胃腺癌的二线治疗，与NP相比，Cam-NP显著提高了ORR和PFS。需要更大规模的研究和生物标志物探索来验证这些发现。
试验注册
ClinicalTrials.gov，NCT04294784，2020年2月3日。
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