Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat Syndrome

NCT07691645 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT-2026-288
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HCC - Hepatocellular Carcinoma; ICG (Indocyanine Green); Quality of Life; Chinese Herbal Medicine; Overall Survival (All-cause Mortality)

Keywords

Hepatocellular Carcinoma(HCC); Chinese herbal medicine; Shuganhuazhuo Formula(SHF); Liver reserve function; Overall survival; Quality of life

Outcome Measures

Primary Outcomes (1)

• Liver reserve function

  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 Outcomes (2)

• Overall Survival

  Through study completion, an average of 2 years.

• Health-related Quality of Life

  Through baseline and intervention period, up to 6 months.

Other Outcomes (2)

• Incidence of adverse reactions

  Through study completion, an average of 1 year.

• Incidence of severe adverse reactions

  Through study completion, an average of 1 year.

Study Arms (2)

Control group

OTHER

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; Drug: Immunotherapy; Drug: Chemotherapy; Procedure: TACE; Procedure: HAIC

traditional Chinese medicine group

EXPERIMENTAL

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: Shuganhuazhuo Formula; Drug: Targeted therapy; Drug: Immunotherapy; Drug: Chemotherapy; Procedure: TACE; Procedure: HAIC

Interventions

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).

traditional Chinese medicine group

Targeted therapy DRUG

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

Control group; traditional Chinese medicine group

Immunotherapy DRUG

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

Control group; traditional Chinese medicine group

Chemotherapy DRUG

Chemotherapy, including but not limited to the FOLFOX4 regimen.

Control group; traditional Chinese medicine group

TACE PROCEDURE

Transcatheter Arterial Chemoembolization(TACE)

Also known as: Transcatheter Arterial Chemoembolization

Control group; traditional Chinese medicine group

HAIC PROCEDURE

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

Also known as: Hepatic Arterial Infusion Chemotherapy

Control group; traditional Chinese medicine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang-Qian: lead
• HerbMed Group Co., Ltd.: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immunotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Li Bing, PhD.

  HerbMed Group Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Zhen Hongde, Dr.

CONTACT

+86 15258827782; zhenhongde@126.com

Li Bing, PhD.

CONTACT

herb@herbmed.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operators performing indocyanine green testing and those responsible for follow-up of overall survival are masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2031
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

CN (1)