Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat Syndrome (DAWNbreak-120)

July 8, 2026 updated by: Xiang-Qian

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Barcelona Clinic Liver Cancer (BCLC) stage is C.
  3. Planning to receive second-line or third-line anti-tumor therapies.
  4. The dominant syndrome in traditional Chinese medicine diagnosis is damp or heat.
  5. Age: ≥ 18 years and ≤ 75 years.

Exclusion Criteria:

  1. Expected survival is less than 3 months.
  2. Definitive pathological diagnosis of intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma (cHCC-CCA).

  3. Comorbid severe heart, liver, kidney dysfunction:

    1. heart

      • New York Heart Association(NYHA) cardiac function > class II

    2. 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

    3. kidney

      • creatinine clearance (Cockcroft-Gault) < 60 mL/min)
  4. Concurrent with other malignant tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
The control group receives anti-tumor treatments recommended by guidelines, including targeted therapy, immunotherapy, and chemotherapy. These treatments can also be combined with transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC). The above conventional anti-tumor therapies are selected by clinicians based on clinical needs.
Drug: Targeted therapy
Targeted therapy, with agents including but not limited to regorafenib and apatinib.
Drug: Immunotherapy
Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.
Drug: Chemotherapy
Chemotherapy, including but not limited to the FOLFOX4 regimen.
Procedure: TACE
Transcatheter Arterial Chemoembolization(TACE)
Other Names:
  • Transcatheter Arterial Chemoembolization
Procedure: HAIC
Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.
Other Names:
  • Hepatic Arterial Infusion Chemotherapy
Experimental: traditional Chinese medicine group
The traditional Chinese medicine (TCM) group receives the Shuganhuazhuo Formula (Chinese herbal medicine) combined with conventional anti-tumor therapies. Monthly follow-ups are conducted to assess the patient's traditional Chinese medicine syndrome type. If there is a change in the syndrome type, the use of the Shuganhuazhuo Formula is discontinued, while anti-tumor therapy continues. The experimental treatment lasts for 6 months. The conventional anti-tumor therapies are selected by clinicians based on clinical needs.
Drug: Targeted therapy
Targeted therapy, with agents including but not limited to regorafenib and apatinib.
Drug: Immunotherapy
Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.
Drug: Chemotherapy
Chemotherapy, including but not limited to the FOLFOX4 regimen.
Procedure: TACE
Transcatheter Arterial Chemoembolization(TACE)
Other Names:
  • Transcatheter Arterial Chemoembolization
Procedure: HAIC
Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.
Other Names:
  • Hepatic Arterial Infusion Chemotherapy
Drug: Shuganhuazhuo Formula
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through baseline and intervention period, up to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 years.
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).
Through baseline and intervention period, up to 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiang-Qian

Collaborators

HerbMed Group Co., Ltd.

Investigators

  • Study Chair: Li Bing, PhD., HerbMed Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2031

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2026-288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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