Efficacy evaluation of Fuzheng Jiedu Xiaoji decoction in the treatment of Hepatitis B - related advanced liver cancer and key components research

Phase 1

• Conditions: iver Cancer

• Registration Number: ITMCTR2000002936
• Lead Sponsor: Beijing Ditan Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Meet the diagnostic criteria for hepatocellular carcinoma;
(2) Chronic hepatitis B virus infection;
(3) Patients with BCLC stage C and D;
(4) Men or women aged 18-65 years;
(5) TCM syndrome differentiation of deficiency of qi and yin, accumulation of poison stasis;
(6) Signing of informed consent.

Exclusion Criteria

(1) Those who have a history of allergies to the applied Chinese medicine components;
(2) Overlapping hepatitis A, E or C and other hepatitis virus infections;
(3) Combining autoimmune hepatitis, drug-induced hepatitis, alcoholic liver disease, and various genetic metabolic liver diseases;
(4) Tuberculosis infection;
(5) HIV-infected patients;
(6) Patients with severe heart and kidney complications or other primary diseases;
(7) Patients with liver cancer metastasized from other tumors or patients with malignant tumors in other locations;
(8) Upper gastrointestinal bleeding;
(9) Hepatorenal syndrome;
(10) Pregnant or lactating women;
(11) People with mental illness who cannot cooperate; patients with a history of epilepsy and central nervous system disease.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival of 48 weeks;

Secondary Outcome Measures

Name	Time	Method
TCM Syndrome Points;Medium survival time;AFP level;Child-Pugh class;Solid tumor remission rate;Complication rate;Liver function;