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

NCT ID: NCT06923176

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 704 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-19
• Study Completion Date: 2031-04-30

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Conventional treatment

Group Type: PLACEBO_COMPARATOR

Routine medical care

Intervention Type: OTHER

Routine medical care

Treatment group

Conventional treatment plus Biejia-Ruangan compound

Group Type: EXPERIMENTAL

Biejia-Ruangan compound

Intervention Type: DRUG

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.

Routine medical care

Intervention Type: OTHER

Routine medical care

Interventions

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.

Intervention Type: DRUG

Routine medical care

Routine medical care

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhiyun Yang

OTHER

Sponsor Role: lead

Responsible Party

Zhiyun Yang

Vice President of Beijing Ditan Hospital Affiliated to Capital Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Zhiyun Yang, Doctor

Role: CONTACT

13439696988@163.com

+86 13439696988

Other Identifiers

BJDHYZYBRC

Identifier Type: -

Identifier Source: org_study_id