四君子汤颗粒治疗晚期难治性结直肠癌：一项多中心、随机、双盲、安慰剂对照试验的研究方案
Sijunzi decoction granules for the treatment of advanced refractory colorectal cancer: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.
作者信息
Nie Shuchang, Su Yingyu, Lu Lu, Jing Yanhua, Jiang Zenghua, Xu Yangxian, Wu Tingting, Zhong Yi, Wu Hao, Chen Junming, Ruan Ming, Zheng Lan, Wang Liyu, Gong Yabin, Ji Guang, Xu Hanchen
机构信息
Institute of Digestive Diseases, Longhua Hospital, China-Canada Center of Research for Digestive Diseases (ccCRDD), Shanghai University of Traditional Chinese Medicine, Shanghai, China.
State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine (Shanghai University of Traditional Chinese Medicine), Shanghai, China.
出版信息
Front Med (Lausanne). 2025 Mar 20;12:1523913. doi: 10.3389/fmed.2025.1523913. eCollection 2025.
BACKGROUND
Colorectal cancer (CRC) ranks among the most common gastrointestinal cancers globally, with both its incidence and mortality rates showing an upward trend. In particular, the 5-year survival rate for stage IV CRC patients is only 14%. Conventional treatments such as chemotherapy and immunotherapy can lead to drug resistance, exacerbate gastrointestinal function damage, and induce immunosuppression. Sijunzi decoction (SJZD), as a fundamental formula of Traditional Chinese medicine (TCM), has been demonstrated to confer distinct advantages in treatment of CRC. Therefore, we designed this trial to explore the efficacy of SJZD for the treatment of advanced refractory CRC.
METHODS
A multicenter, randomized, double-blind, placebo-controlled trial is being conducted to assess the effectiveness of SJZD combined with standard therapy for treating advanced refractory CRC. Patients with advanced CRC will be recruited and randomly allocated to either the SJZD treatment group or the placebo group in a 1:1 ratio. Both groups will receive standard treatment. The intervention period will last for 6 months, with follow-up assessments every 8 to 10 weeks. Progression-free survival (PFS) is the main outcome measure. And the secondary outcomes contain duration of disease control (DDC), overall survival (OS), completion rate of chemotherapy, incidence of treatment-related adverse events, quality of survival scale score for tumor patients and changes in spleen deficiency patient-reported outcome (PRO) scores following the intervention.
EXPECTED OUTCOMES
To the best of our knowledge, this trial marks the first clinical investigation into the therapeutic potential of SJZD for managing advanced refractory CRC. The primary aim of this study is to provide robust clinical evidence to support the integration of TCM with Western medicine in the treatment of advanced refractory CRC.
TRIAL REGISTRATION
The trial was registered at Chinese Clinical Trial Registry, http://www.chictr.org.cn (Registration No: ChiCTR2200065434); Date: 2022-11-04.
背景
结直肠癌（CRC）是全球最常见的胃肠道癌症之一，其发病率和死亡率均呈上升趋势。特别是，IV期CRC患者的5年生存率仅为14%。化疗和免疫治疗等传统治疗方法可导致耐药性，加剧胃肠功能损害，并诱导免疫抑制。四君子汤（SJZD）作为中医的基础方剂，已被证明在CRC治疗中具有显著优势。因此，我们设计了本试验，以探索SJZD治疗晚期难治性CRC的疗效。
方法
正在进行一项多中心、随机、双盲、安慰剂对照试验，以评估SJZD联合标准疗法治疗晚期难治性CRC的有效性。将招募晚期CRC患者，并以1:1的比例随机分配至SJZD治疗组或安慰剂组。两组均接受标准治疗。干预期将持续6个月，每8至10周进行一次随访评估。无进展生存期（PFS）是主要结局指标。次要结局包括疾病控制持续时间（DDC）、总生存期（OS）、化疗完成率、治疗相关不良事件的发生率、肿瘤患者生存质量量表评分以及干预后脾虚患者报告结局（PRO）评分的变化。
预期结果
据我们所知，本试验是首次对SJZD治疗晚期难治性CRC的治疗潜力进行的临床研究。本研究的主要目的是提供有力的临床证据，以支持中西医结合治疗晚期难治性CRC。
试验注册
该试验已在中国临床试验注册中心注册，网址为http://www.chictr.org.cn（注册号：ChiCTR2200065434）；日期：2022年11月4日。
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