HCC - Hepatocellular CarcinomaPhase 2DAWNbreak-120NCT07691645
Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat Syndrome
A Phase 2 study testing Shuganhuazhuo Formula, Targeted therapy and Immunotherapy in people with HCC - Hepatocellular Carcinoma and Chinese Herbal Medicine, run by Xiang-Qian at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Chinese Herbal Medicine, ICG (Indocyanine Green)
- What is being tested?
- Shuganhuazhuo Formula, Targeted therapy and Immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2027to 31 Aug 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Li Bing, PhD. contact
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhen Hongde, Dr., +86 15258827782, zhenhongde@126.com
About this study
Official 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
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, Chinese Herbal Medicine, ICG (Indocyanine Green), Overall Survival (All-cause Mortality), Quality of Life
- Being tested
- Shuganhuazhuo Formula, Targeted therapy, Immunotherapy, Chemotherapy, TACE
- Keywords
- Hepatocellular Carcinoma(HCC), Chinese herbal medicine, Shuganhuazhuo Formula(SHF), Liver reserve function, Overall survival, Quality of life
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shuganhuazhuo FormulaDrug
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 therapyDrug
Targeted therapy, with agents including but not limited to regorafenib and apatinib.
ImmunotherapyDrug
Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.
ChemotherapyDrug
Chemotherapy, including but not limited to the FOLFOX4 regimen.
TACEProcedure or surgery
Also called Transcatheter Arterial Chemoembolization
Transcatheter Arterial Chemoembolization(TACE)
HAICProcedure or surgery
Also called Hepatic Arterial Infusion Chemotherapy
Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Shuganhuazhuo Formula; Drug: Targeted therapy; Drug: Immunotherapy; Drug: Chemotherapy; Procedure: TACE; Procedure: HAIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver reserve function
Assessment is based on the indocyanine green retention rate at 15 minutes (ICG-R15) from the indocyanine green clearance Test.
Measured: Through baseline and intervention period, up to 6 months.
Secondary outcomes (2)
Overall Survival
The time elapsed from the subject's randomization to death due to any cause.
Measured: Through study completion, an average of 2 years.
Health-related Quality of Life
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).
Measured: Through baseline and intervention period, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2027 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang-Qian
- Sponsor type
- University, hospital or other
- Collaborators
- HerbMed Group Co., Ltd.
- Responsible party
- Sponsor-investigator, Xiang-Qian, Zhejiang Cancer Hospital
- Investigators
- Li Bing, PhD., Study chair, HerbMed Group Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691645
- Sponsor's protocol ID
- IIT-2026-288
- Acronym
- DAWNbreak-120
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided