nab -紫杉醇联合Camrelizumab与nab -紫杉醇单独作为晚期胃癌二线治疗的多中心II期研究

IF 4.8 2区医学 Q1 ONCOLOGY

Oncologist Pub Date : 2025-06-24 DOI:10.1093/oncolo/oyaf189

Li Sun, Zhimin Gong, Lei Wang, Li Kuang, Qiao Huang, Bo Pei, Xianglin Yuan, Hong Qiu

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引用次数: 0

摘要

背景：nab -紫杉醇是晚期胃癌的标准二线治疗，但PD-1抑制剂的作用仍不确定。这项多中心、随机II期试验评估了nab-紫杉醇联合camrelizumab （Cam-NP）与nab-紫杉醇单用（NP）治疗对既往治疗耐药的晚期胃腺癌患者的疗效。方法：患者随机接受Cam-NP或NP治疗，直到疾病进展、无法忍受的毒性或同意退出。主要终点是总缓解率（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例患者随机分组，其中58例接受治疗。在中位随访34.5个月时，Cam-NP组的ORR显著提高(33.3% vs. 10.7%；p = 0.039)和更长的中位PFS (5.62 vs 4.21个月；P = 0.006)。中位反应持续时间也有利于Cam-NP(4.64个月vs 2.96个月；P = 0.058)。而Cam-NP组的OS较长(9.8个月vs. 7.2个月；P = 0.087)，差异无统计学意义。最常见的3-4级不良事件是血液毒性。结论：与NP相比，Cam-NP作为晚期胃腺癌的二线治疗可显著改善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。

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Multi-Center Phase II Study of Nab-Paclitaxel Plus Camrelizumab Versus Nab-Paclitaxel Alone as Second-Line Treatment for Advanced Gastric Cancer.

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: 61 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 = 0.039) and longer median PFS (5.62 vs. 4.21 months; p = 0.006). Median response duration also favored Cam-NP (4.64 vs. 2.96 months; p = 0.058). While the Cam-NP group showed a longer OS (9.8 vs. 7.2 months; p = 0.087), 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.

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来源期刊

Oncologist 医学-肿瘤学

CiteScore

10.40

自引率

3.40%

发文量

309

审稿时长

3-8 weeks

期刊介绍： The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.