Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat Syndrome

Primary liver cancer is a malignant tumor with a very poor prognosis. Hepatocellularcarcinoma(HCC) accounts for approximately 80% of cases. Under the current targeted andimmunotherapy‐based treatment approaches, the overall survival of patients with advancedHCC has improved significantly compared to targeted therapy alone. However, there arestill limitations in therapeutic effectiveness. In addition to the tumor burden, liverreserve function is associated with the prognosis of HCC. Cirrhosis, tumor burden, andanti‐tumor treatment can all lead to damage to liver reserve function, which in turnleads to a decrease in patient survival. Currently, there are no specific treatments fordeteriorating liver reserve function; only symptomatic treatments such as reducingtransaminase levels, bilirubin levels, and blood ammonia levels, as well as diuretics,are available. The indocyanine green(ICG) clearance test allows for precise, dynamic, andquantitative measurement of liver clearance function, making it a commonly used methodfor assessing liver reserve function in clinical practice.Previous studies have confirmedthat its test results are closely related to the prognosis of HCC.Shuganhuazhuo Formula(SHF) is a Chinese herbal medicine used to treat advanced HCC withsyndrome of Damp‐Heat and Blood stasis. It can inhibit necrosis in the livers of mice inexperimental models, reduce fibrosis scores, and demonstrate potential therapeuticeffects in protecting the liver, reducing oxidative stress, and preventing fibrosis.This study is an open‐label randomized controlled trial. Patients with advanced HCC whoare receiving second‐line or third‐line anti‐tumor treatment are randomly assigned in a1:1 ratio to either the control group or the traditional Chinese medicine (TCM) group.The control group receives anti‐tumor treatment as recommended by guidelines, while theTCM group receives additional treatment with SHF. SHF involves decocting traditionalChinese medicine ingredients twice daily. Each time, 150 ml of the decoction is preparedand taken orally half an hour after breakfast and dinner. Treatment lasts for 6 months.During this period, the ICG clearance test is performed every 2 months to assess liverreserve function, and quality of life is also evaluated. After the treatment period,follow‐ups on survival and safety are conducted every 3 months. This study aims toevaluate the benefits of the SHF in terms of liver reserve function, overall survival,and quality of life in patients with HCC of the syndrome of Damp‐Heat and Blood stasis.It also includes exploratory analyses of differences in biomarker expression duringtreatment.