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

April 4, 2025 updated by: Zhiyun Yang

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

704

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Conventional treatment
Other: Routine medical care
Routine medical care
Experimental: Treatment group
Conventional treatment plus Biejia-Ruangan compound
Other: Routine medical care
Routine medical care
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival
Time Frame: 96 weeks
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: 96 weeks
96 weeks
quality of life (QOL) questionnaire
Time Frame: 96 weeks
The questionnaire includes appetite, sleep, fatigue, pain, etc.
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhiyun Yang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 19, 2025

Primary Completion (Estimated)

April 30, 2031

Study Completion (Estimated)

April 30, 2031

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJDHYZYBRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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