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

8 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310022
        • Zhejiang Cancer Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Droga: Targeted therapy
Targeted therapy, with agents including but not limited to regorafenib and apatinib.
Droga: Immunotherapy
Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.
Droga: Chemotherapy
Chemotherapy, including but not limited to the FOLFOX4 regimen.
Procedura: TACE
Transcatheter Arterial Chemoembolization(TACE)
Altri nomi:
  • Chemioembolizzazione arteriosa transcatetere
Procedura: HAIC
Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.
Altri nomi:
  • Hepatic Arterial Infusion Chemotherapy
Sperimentale: 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.
Droga: Targeted therapy
Targeted therapy, with agents including but not limited to regorafenib and apatinib.
Droga: Immunotherapy
Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.
Droga: Chemotherapy
Chemotherapy, including but not limited to the FOLFOX4 regimen.
Procedura: TACE
Transcatheter Arterial Chemoembolization(TACE)
Altri nomi:
  • Chemioembolizzazione arteriosa transcatetere
Procedura: HAIC
Hepatic Arterial Infusion Chemotherapy(HAIC), including but not limited to the FOLFOX regimen.
Altri nomi:
  • Hepatic Arterial Infusion Chemotherapy
Droga: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Liver reserve function
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of adverse reactions
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xiang-Qian

Collaboratori

HerbMed Group Co., Ltd.

Investigatori

  • Cattedra di studio: Li Bing, PhD., HerbMed Group Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 agosto 2029

Completamento dello studio (Stimato)

31 agosto 2031

Date di iscrizione allo studio

Primo inviato

29 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IIT-2026-288

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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