Status:
NOT_YET_RECRUITING
Effect of Biejia-Ruangan Compound on Survival Rate and Recurrence Rate of Hepatocellular Carcinoma After Radical Treatment
Lead Sponsor:
Zhiyun Yang
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 (convent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2031
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT06923176
Start Date
April 19 2025
End Date
April 30 2031
Last Update
April 11 2025
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