Hepatocellular carcinoma
Conditions
Interventions
the Huqizhengxiao (HQZX) formula plus Western Medicine Treatment Group: Besides of Western medical treatment, the Huqizhengxiao (HQZX) formula will be given to the patients according to the symptoms a
Western Medicine Treatment Group:Western medical treatment will be given to the HCC patients according to the HCC guideline.
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18~75 years old, male or female; 2) Meet the diagnostic criteria for chronic hepatitis B and cirrhosis as stipulated in the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 edition) and the Guidelines for the Diagnosis and Treatment of Cirrhosis of the Liver (2019 edition); 3) Be diagnosed for the first time as HCC and meet the diagnostic conditions of stage I, II, III, and IV according to the diagnostic criteria and clinical staging of primary liver cancer diagnosis and treatment guideline (2022 edition) (see Exhibit 2); 4) Enhanced imaging with at least one measurable lesion for objective tumor response evaluation; 5) A score of greater than or equal to 60 points according to the TCM symptom scale (see Exhibit 6); 6) Ability to provide informed consent.
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding women. 2) Comorbid human immunodeficiency virus (HIV) infection or other serious infectious diseases; 3) Those with comorbid severe cardiopulmonary disease, diabetes, primary kidney disease, multiple organ failure, other serious systemic diseases, and psychiatric patients; 4) Those with coexisting active hepatitis or serious infections that cannot be treated at the same time; 5) Those with expected survival <3 months; 6) those with cirrhosis and hepatocellular carcinoma due to causes other than hepatitis B virus; 7) severe hepatic artery-portal vein fistula or hepatic artery-hepatic vein and it is not easy to embolize and seal; 8) Those who are allergic to iodine or cannot improve enhanced CT or MRI for other reasons; 9) those with currently active gastrointestinal bleeding, or those with a history of gastrointestinal bleeding in the last 2 weeks; 10) Patients with combination of other malignant tumors; 11) Application of other modern Chinese medicinal preparations with indications for the treatment of hepatocellular carcinoma (including but not limited to: Kang Lai Te injection/soft capsule, Aidi injection, Kang Ai injection, Eleutherococcus injection, Huazhuazin capsule, Hepatoflex, Sophora ear granules, etc.); 12) Not signing the informed consent form; 13) Other conditions that the investigator considers unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate;Quality of life scores;Chinese Medicine Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;progression-free survival, PFS;Duration of Response, DOR;time-to-progression, TTP; | — |
Countries
China
Contacts
Public ContactXiaojun Wang
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed