Sijunzi decoction granules for the treatment of advanced refractory colorectal cancer: Study protocol for a multicentre, randomized, double-blind, placebo-controlled trial

Shuchang Nie ¹ Yingyu Su ¹ Lu Lu ¹ Yanhua Jing ¹ Zenghua Jiang ² Yangxian Xu ² Tingting Wu ³ Yi Zhong ³ Hao Wu ⁴ Junming Chen ⁴ Ming Ruan ⁵ Lan Zheng ⁵ Liyu Wang ⁶ Yabin Gong ⁶ Guang Ji ^1* Hanchen Xu ^1*

• ¹ Institute of Digestive Diseases, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China
• ² Department II of General Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
• ³ Shanghai TCM-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai Municipality, China
• ⁴ Minhang Hospital, Fudan University, Shanghai, Shanghai Municipality, China
• ⁵ Department of Traditional Chinese Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
• ⁶ Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

Background: Colorectal cancer (CRC) is one of the most prevalent gastrointestinal malignancies worldwide, and its incidence and mortality rate are increasing. 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. Guided by traditional Chinese medicine (TCM), patients with CRC are usually treated with Sijunzi decoction (SJZD). Therefore, this trial aims to explore the efficacy and safety of SJZD for the treatment of advanced refractory CRC.Methods: A multicentre, randomized, double-blind, placebo-controlled trial is being conducted to evaluate the efficacy of SJZD combined with standard therapy for treating advanced refractory CRC. Patients with advanced CRC will be enrolled and randomly assigned to either the SJZD group or the placebo group at 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. The primary outcome is progression-free survival (PFS). The secondary outcomes include duration of disease control (DDC), overall survival (OS), completion rate of chemotherapy, incidence of treatment-related adverse events, quality of survival scale score for tumour patients and changes in spleen deficiency patient-reported outcome (PRO) scores after the intervention.