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NCT06923176

PHASE4

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

Sponsor: Zhiyun Yang

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

704

Start Date

2025-04-19

Completion Date

2031-04-30

Last Updated

2025-04-11

Healthy Volunteers

Conditions

Hepatocellular Carcinoma (HCC)

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

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.