Department of Colorectal Cancer Center, Sichuan University West China Hospital, Chengdu, Sichuan, China.
Department of Biotherapy, Sichuan University West China Hospital, Chengdu, Sichuan, China.
BMJ Open. 2023 Jan 31;13(1):e062659. doi: 10.1136/bmjopen-2022-062659.
Neoadjuvant chemotherapy (NAC) has been demonstrated effective in several tumours, but its benefit has not yet been elucidated in colorectal cancer, especially locally advanced colorectal cancer (LACRC).
This is a single-arm, open-label, prospective phase II exploratory clinical trial. Patients with LACRC will receive four cycles of NAC with 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI), followed by operation and then adjuvant chemotherapy with capecitabine and oxaliplatin for two to five cycles or single-agent capecitabine for five cycles, or observation. The primary endpoint is the rate of tumour regression grade (TRG) 0-2 in the resected tumour tissue, which is evaluated by experienced pathologists according to the Ryan R TRG grading system. Secondary endpoints include objective response rate, pathologic complete response, microscopically complete resection rate, progression-free survival, distant metastasis-free survival, overall survival, toxicity and compliance to study treatment, molecular markers, quality of life to study treatment and the number of patients with 30-day postoperative mortality. The objective of this study is to analyse the efficacy and safety of FOLFOXIRI as the NAC regimen in patients with LACRC and to identify a promising treatment strategy in this setting.
Written informed consent will be required from and provided by all patients enrolled. The study protocol has been approved by the independent ethics committee of West China Hospital, Sichuan University (approval number: 2021403). This study will demonstrate the potential benefit of NAC with the FOLFOXIRI regimen. Results will be shared with policymakers and the academic community to promote the clinical management of colon cancer.
NCT05018182.
新辅助化疗（NAC）已在多种肿瘤中显示出疗效，但尚未在结直肠癌中阐明其益处，尤其是局部晚期结直肠癌（LACRC）。
这是一项单臂、开放标签、前瞻性 II 期探索性临床试验。LACRC 患者将接受四个周期的 5-氟尿嘧啶、奥沙利铂和伊立替康（FOLFOXIRI）新辅助化疗，然后进行手术，随后接受卡培他滨和奥沙利铂辅助化疗两到五个周期或单药卡培他滨五个周期，或观察。主要终点是切除肿瘤组织中肿瘤退缩分级（TRG）0-2 的发生率，由经验丰富的病理学家根据 Ryan R TRG 分级系统进行评估。次要终点包括客观缓解率、病理完全缓解率、显微镜下完全切除率、无进展生存期、无远处转移生存期、总生存期、毒性和对研究治疗的依从性、分子标志物、对研究治疗的生活质量以及 30 天术后死亡率为 30 天的患者人数。本研究的目的是分析 FOLFOXIRI 作为 LACRC 患者新辅助化疗方案的疗效和安全性，并确定该治疗方案在该人群中的潜在治疗策略。
所有入组患者均需提供并获得书面知情同意。该研究方案已获得四川大学华西医院独立伦理委员会的批准（批准号：2021403）。本研究将证明 FOLFOXIRI 方案新辅助化疗的潜在益处。结果将与决策者和学术界共享，以促进结肠癌的临床管理。
NCT05018182。
