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

Launched by ZHIYUN YANG · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Biejia-Ruangan compound on patients with hepatocellular carcinoma (HCC), a type of liver cancer, after they have undergone major surgery or other radical treatments. The study will involve 704 patients who have a history of chronic hepatitis B and have completed their initial cancer treatment. Participants will be divided into two groups: one receiving standard treatment and the other receiving standard treatment plus the Biejia-Ruangan compound for 72 weeks. Researchers will follow up with participants for a total of 240 weeks to see how well this combination therapy works in preventing cancer from coming back and improving overall survival rates.

To be eligible for this trial, participants must be between 18 and 75 years old, have been diagnosed with HCC, and completed radical treatment with no signs of remaining cancer. They should also have liver health classified as Child Pugh score A or B. However, individuals who are pregnant, have certain mental health conditions, or have recently received other cancer treatments are not eligible. If you decide to participate, you can expect regular check-ups and assessments to monitor your health throughout the study. This trial aims to provide valuable insights into how the Biejia-Ruangan compound may help improve outcomes for patients with liver cancer.

Gender

ALL

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.