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

NCT06923176 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: BJDHYZYBRC
• Study Type: interventional
• Target: 704
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  96 weeks

Secondary Outcomes (2)

• Overall survival rate

  96 weeks

• quality of life (QOL) questionnaire

  96 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

Conventional treatment

Other: Routine medical care

Treatment group

EXPERIMENTAL

Conventional treatment plus Biejia-Ruangan compound

Drug: Biejia-Ruangan compound; Other: Routine medical care

Interventions

Biejia-Ruangan compound 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.

Treatment group

Routine medical care OTHER

Routine medical care

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhiyun Yang: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Zhiyun Yang, Doctor

CONTACT

+86 13439696988; 13439696988@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Beijing Ditan Hospital Affiliated to Capital Medical University

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: April 19, 2025
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2031
• Last Updated: April 11, 2025

Record last verified: 2025-04