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

8. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Medicin: Targeted therapy
Targeted therapy, with agents including but not limited to regorafenib and apatinib.
Medicin: Immunotherapy
Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.
Medicin: Chemotherapy
Chemotherapy, including but not limited to the FOLFOX4 regimen.
Procedure: TACE
Transcatheter Arterial Chemoembolization(TACE)
Andre navne:
  • Transkateter arteriel kemoembolisering
Procedure: HAIC
Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.
Andre navne:
  • Hepatic Arterial Infusion Chemotherapy
Eksperimentel: 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.
Medicin: Targeted therapy
Targeted therapy, with agents including but not limited to regorafenib and apatinib.
Medicin: Immunotherapy
Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.
Medicin: Chemotherapy
Chemotherapy, including but not limited to the FOLFOX4 regimen.
Procedure: TACE
Transcatheter Arterial Chemoembolization(TACE)
Andre navne:
  • Transkateter arteriel kemoembolisering
Procedure: HAIC
Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.
Andre navne:
  • Hepatic Arterial Infusion Chemotherapy
Medicin: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Liver reserve function
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of adverse reactions
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xiang-Qian

Samarbejdspartnere

HerbMed Group Co., Ltd.

Efterforskere

  • Studiestol: Li Bing, PhD., HerbMed Group Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. august 2029

Studieafslutning (Anslået)

31. august 2031

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IIT-2026-288

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