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NCT Number: NCT07691645

Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat Syndrome

Primary liver cancer is a malignant tumor with a very poor prognosis. Hepatocellular carcinoma(HCC) accounts for approximately 80% of cases. Under the current targeted and immunotherapy-based treatment approaches, the overall survival of patients with advanced HCC has improved significantly compared to targeted therapy alone. However, there are still limitations in therapeutic effectiveness. In addition to the tumor burden, liver reserve function is associated with the prognosis of HCC. Cirrhosis, tumor burden, and anti-tumor treatment can all lead to damage to liver reserve function, which in turn leads to a decrease in patient survival. Currently, there are no specific treatments for deteriorating liver reserve function; only symptomatic treatments such as reducing transaminase levels, bilirubin levels, and blood ammonia levels, as well as diuretics, are available. The indocyanine green(ICG) clearance test allows for precise, dynamic, and quantitative measurement of liver clearance function, making it a commonly used method for assessing liver reserve function in clinical practice.Previous studies have confirmed that its test results are closely related to the prognosis of HCC.

Shuganhuazhuo Formula(SHF) is a Chinese herbal medicine used to treat advanced HCC with syndrome of Damp-Heat and Blood stasis. It can inhibit necrosis in the livers of mice in experimental models, reduce fibrosis scores, and demonstrate potential therapeutic effects in protecting the liver, reducing oxidative stress, and preventing fibrosis.

This study is an open-label randomized controlled trial. Patients with advanced HCC who are receiving second-line or third-line anti-tumor treatment are randomly assigned in a 1:1 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 the TCM group receives additional treatment with SHF. SHF involves decocting traditional Chinese medicine ingredients twice daily. Each time, 150 ml of the decoction is prepared and 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 liver reserve 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 to evaluate 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 during treatment.

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Chinese Herbal Medicine Digestive System Diseases Digestive System Neoplasms ICG (Indocyanine Green) Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Overall Survival (All-cause Mortality) Quality of Life

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • According to the National Health Commission(China)'s "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026)", clinically or pathologically diagnosed as primary liver cancer.
  • Barcelona Clinic Liver Cancer (BCLC) stage is C.
  • Planning to receive second-line or third-line anti-tumor therapies.
  • The dominant syndrome in traditional Chinese medicine diagnosis is damp or heat.
  • Age: ≥ 18 years and ≤ 75 years.

Exclusion criteria

  • Expected survival is less than 3 months.
  • Definitive pathological diagnosis of intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma (cHCC-CCA).
  • Comorbid severe heart, liver, kidney dysfunction:
  • heart
  • New York Heart Association(NYHA) cardiac function > class II
  • liver
  • aspartate aminotransferase > 3 times the upper limit of normal
  • alanine aminotransferase > 3 times the upper limit of normal
  • bilirubin > 3 times the upper limit of normal
  • kidney
  • creatinine clearance (Cockcroft-Gault) < 60 mL/min)
  • Concurrent with other malignant tumors.

Treatment and study plan

Shuganhuazhuo Formula

Drug

The Shuganhuazhuo Formula is composed of the following medicinal materials: Bupleuri Radix (Chaihu), Scutellariae Radix (Huangqin), processed Pinelliae Rhizoma (Fabanxia), Ginseng Radix et Rhizoma (Renshen, sliced), Agrimoniae Herba (Xianhecao), stir-fried Arecae Semen (Chao Binglang), stir-fried Aurantii Fructus (Chao Zhiqiao), Artemisiae Scopariae Herba (Yinchen), and other ingredients.The formula contains no toxic or strongly drastic medicinal substances, and the dosages of all herbal ingredients are within the ranges specified in the Pharmacopoeia of the People's Republic of China (2025, Volume I).

targeted therapy

Drug

Targeted therapy, with agents including but not limited to regorafenib and apatinib.

Immunotherapy

Drug

Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.

Chemotherapy

Drug

Chemotherapy, including but not limited to the FOLFOX4 regimen.

TACE

Procedure

Transcatheter Arterial Chemoembolization(TACE)

Other names: Transcatheter Arterial Chemoembolization

HAIC

Procedure

Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.

Other names: Hepatic Arterial Infusion Chemotherapy

Primary outcomes

  1. Liver reserve function

    Time frame: Through baseline and intervention period, up to 6 months.

    Assessment is based on the indocyanine green retention rate at 15 minutes (ICG-R15) from the indocyanine green clearance Test.

Secondary outcomes

  1. Overall Survival

    Time frame: Through study completion, an average of 2 years.

    The time elapsed from the subject's randomization to death due to any cause.

  2. Health-related Quality of Life

    Time frame: Through baseline and intervention period, up to 6 months.

    Assessment is conducted using the European Organization for Research and Treatment of Cancer's Core Quality of Life Scale (EORTC QLQ-C30) combined with the 18 items of the Hepatocellular Liver Carcinoma-Specific Quality of Life Supplement Module (EORTC QLQ-HCC18).

Other outcomes

  1. Incidence of adverse reactions

    Time frame: Through study completion, an average of 1 year.

    During the study, the incidence of adverse events (AEs) that are assessed as Definite, Probable, or Possible to the trial drug is determined. The assessment of the relationship between adverse events and the trial drug is conducted in accordance with the "Technical Guidelines for Evaluating the Association between Adverse Events and Drugs in Clinical Trials" issued by the National Medical Products Administration's Center for Drug Evaluation. The five-point attribution scale developed by the Cancer Treatment Evaluation Program (CTEP) of the National Cancer Institute in the United States is also used for evaluation.

  2. Incidence of severe adverse reactions

    Time frame: Through study completion, an average of 1 year.

    During the study, the incidence of adverse events (AEs) that are assessed as Definite, Probable, or Possible to the trial drug is determined. The assessment of the relationship between adverse events and the trial drug is conducted in accordance with the "Technical Guidelines for Evaluating the Association between Adverse Events and Drugs in Clinical Trials" issued by the National Medical Products Administration's Center for Drug Evaluation. The five-point attribution scale developed by the Cancer Treatment Evaluation Program (CTEP) of the National Cancer Institute in the United States is also used for evaluation.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Bing, PhD.

CONTACT

[email protected]

Zhen Hongde, Dr.

CONTACT

[email protected]

+86 15258827782

Sponsors and collaborators

Lead sponsor

Xiang-Qian

Other

Collaborators

  • HerbMed Group Co., Ltd.

Registry information

Official study title

Shuganhuazhuo Formula (Chinese Herbal Medicine) in the Combined Treatment of Advanced Hepatocellular Carcinoma With Damp-Heat and Blood Stasis Syndrome: An Open-Label Randomized Controlled Trial

Acronym: DAWNbreak-120

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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