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Not yet recruiting NCT06923176

Effect of Biejia-Ruangan Compound on Survival Rate and Recurrence Rate of Hepatocellular Carcinoma After Radical Treatment

Phase IV Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biejia-Ruangan compound, Routine medical care.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study plans to enroll 704 patients with a history of chronic hepatitis B who have undergone radical treatment for hepatocellular carcinoma. The subjects were divided into a control group (conventional treatment group) and a combination therapy group (conventional treatment plus Biejia-Ruangan compound) according to the doctor's clinical diagnosis and treatment and the subjects' wishes in a ratio of 1:2. The subjects in the combination therapy group were treated with Biejia-Ruangan compound for 72 weeks, followed by 168 weeks of follow-up, for a total study period of 240 weeks. By analyzing the 1-, 2-, 3-, and 5-year recurrence-free, overall survival rate/survival time, adverse reactions, etc., the clinical effect of Biejia-Ruangan compound in reducing the risk of recurrence in patients with hepatocellular carcinoma after receiving radical treatment was comprehensively evaluated, and its scientific value and practical application prospects as a potential treatment method were explored.

Interventions

  • Drug Biejia-Ruangan compound
    Biejia-Ruangan compound have the functions of softening hardness, dispersing lumps, removing blood stasis and detoxifying, and nourishing qi and blood. Used for chronic hepatitis B liver fibrosis, as well as early liver cirrhosis characterized by blood stasis obstructing collaterals, qi and blood deficiency with incomplete heat toxicity.
  • Other Routine medical care
    Routine medical care

Primary outcome measures

  • Recurrence-free survival [Time frame: 96 weeks]
Secondary outcome measures (2)
  • Overall survival rate [Time frame: 96 weeks]
  • quality of life (QOL) questionnaire [Time frame: 96 weeks]

Eligibility criteria

Inclusion criteria

  • Age range: 18-75 years old (including 18 and 75 years old), regardless of gender.
  • Individuals with chronic hepatitis B liver fibrosis or cirrhosis.
  • According to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer" (2024 edition) liver cancer diagnosis roadmap, the first clinical diagnosis is Hepatocellular carcinoma(HCC).
  • The staging of liver cancer is CNLC stage Ia - IIa.
  • Radical treatment has been completed, with surgical resection or local ablation.
  • 8-12 weeks after radical surgery, imaging and serological evaluations showed no residual cancerous lesions and no new cancerous lesions were found.
  • Child Pugh score A/B.
  • Voluntarily joining the group, able to understand and sign an informed consent form.

Exclusion criteria

  • Pregnant and lactating women;
  • Prior to radical liver cancer surgery, the patient had received radiation, chemotherapy, molecular targeting, immunotherapy, and other anti-tumor treatments;
  • Receive other anti-tumor Chinese medicine (including traditional Chinese patent medicines and simple preparations or Chinese herbal medicine);
  • Individuals with mental illnesses, especially those with a history of depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially those with a history of depression or tendencies towards depression);
  • Combination of hepatitis A, C, D, E, and/or current HIV infections;
  • Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, etc., or screening with blood creatinine>2.0 × ULN;
  • Autoimmune diseases, including psoriasis, systemic lupus erythematosus, autoimmune liver disease, etc;
  • Patients who experience upper gastrointestinal bleeding within the first 3 months (including the screening period) prior to screening;
  • Individuals with a serious history of heart disease, especially those with unstable or poorly controlled heart disease within the past 6 months;
  • Individuals who plan to receive organ transplantation or have already undergone organ transplantation;
  • Those who are allergic to Compound Biejia Ruangan Tablets, nucleoside (acid) analogues, or drug excipients, or who meet any contraindications in the experimental drug instructions;
  • Have used other anti fibrotic drugs within the first 6 months of enrollment, such as Fuzheng Huayu, Anluo Huaxian, and Ganshuang Granules.
  • Other situations where the participant has participated in other intervention trials within the previous month or where the researcher deems it unsuitable for inclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06923176 · BJDHYZYBRC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗