Dai Ruihong, Zhang Pengfei, Cheng Mo, Bi Feng, Zhou Jitao, Liu Ming
Interventional Diagnosis and Treatment Center, West China Hospital of Sichuan University, Chengdu, China.
Department of Gastric Cancer Center, Sichuan University, Chengdu, Sichuan Province, China.
BMJ Open. 2026 Jan 9;16(1):e086005. doi: 10.1136/bmjopen-2024-086005.
A combination of chemotherapy and immune checkpoint inhibitor therapy has been demonstrated to be effective as a first-line treatment of gastric or gastro-oesophageal junction (G/GEJ) cancer. The conventional treatment strategy for patients with advanced/metastatic human epidermal growth factor receptor 2-negative G/GEJ cancer is recommended. However, the response rate and enhancements in survival are still significantly insufficient. The present study will investigate the efficacy and safety of incorporating a bevacizumab biosimilar IBI305 into chemotherapy and immunotherapy as a first-line treatment for advanced or metastatic G/GEJ cancer.
This single-arm, open-label, prospective phase Ib/II clinical study will involve 57 participants. In phase Ib of the trial, patients with advanced or metastatic G/GEJ cancer will receive capecitabine and oxaliplatin (CapeOX) together with sintilimab (200 mg intravenously every 3 weeks) and IBI305 (7.5, 10 or 15 mg/kg intravenously every 3 weeks) in a 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs) within 6 weeks of treatment initiation. In phase II, the patients will receive CapeOX combined with sintilimab and IBI305 at the recommended phase II dose. The primary objectives will be to assess DLTs (phase Ib) and the objective response rate (phase II). The secondary objectives will include progression-free survival, overall survival, disease control rate, duration of response, adverse effects, quality of life and safety.
The trial protocol was approved by the Ethics Committee of West China Hospital and ClinicalTrials. The final results will be published in a peer-reviewed journal upon completion of the study.
NCT05640609.
化疗与免疫检查点抑制剂联合治疗已被证明是胃或胃食管交界（G/GEJ）癌一线治疗的有效方法。对于晚期/转移性人表皮生长因子受体2阴性G/GEJ癌患者，推荐采用传统治疗策略。然而，缓解率和生存率的提高仍然明显不足。本研究将调查将贝伐珠单抗生物类似药IBI305纳入化疗和免疫治疗作为晚期或转移性G/GEJ癌一线治疗的疗效和安全性。
本单臂、开放标签、前瞻性Ib/II期临床研究将纳入57名参与者。在试验的Ib期，晚期或转移性G/GEJ癌患者将接受卡培他滨和奥沙利铂（CapeOX）联合信迪利单抗（每3周静脉注射200mg）和IBI305（每3周静脉注射7.5、10或15mg/kg），采用3+3剂量递增设计，在开始治疗的6周内评估剂量限制性毒性（DLTs）。在II期，患者将接受CapeOX联合信迪利单抗和推荐的II期剂量的IBI305。主要目标将是评估DLTs（Ib期）和客观缓解率（II期）。次要目标将包括无进展生存期、总生存期、疾病控制率、缓解持续时间、不良反应、生活质量和安全性。
试验方案已获得四川大学华西医院伦理委员会和ClinicalTrials批准。研究完成后，最终结果将发表在同行评审期刊上。
NCT05640609。
