NCT06923176Not yet recruitingPhase 4
Effect of Biejia-Ruangan Compound on Survival Rate and Recurrence Rate of Hepatocellular Carcinoma After Radical Treatment
Source: ClinicalTrials.gov · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 704 (estimated)
- First submitted
- 4 Apr 2025
- Start date
- 19 Apr 2025
- Primary completion date
- 30 Apr 2031
- Lead sponsor
- Zhiyun Yang
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06923176
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 704
- From 19 Apr 2025 to the primary completion date, 30 Apr 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior to radical liver cancer surgery, the patient had received radiation, chemotherapy, molecular targeting, immunotherapy, and other anti-tumor treatments;
- Patients who experience upper gastrointestinal bleeding within the first 3 months (including the screening period) prior to screening;
- Individuals who plan to receive organ transplantation or have already undergone organ transplantation;
- 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.
Other illness
- 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;
- Autoimmune diseases, including psoriasis, systemic lupus erythematosus, autoimmune liver disease, etc;
- Individuals with a serious history of heart disease, especially those with unstable or poorly controlled heart disease within the past 6 months;
- 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;
Lab values
- Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, etc., or screening with blood creatinine\>2.0 × ULN;
Other
- Pregnant and lactating women;
- Receive other anti-tumor Chinese medicine (including traditional Chinese patent medicines and simple preparations or Chinese herbal medicine);
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.