Primary liver cancer
Conditions
Interventions
Experimental Group:Solidify the Root and Eliminate Accumulation Granules Combined with Targeted Immunotherapy
Control Group:Guben Xieji Granules placebo combined with targeted immunotherapy
Sponsors
Hunan Province Integrated Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years. 2) Patients with hepatocellular carcinoma (HCC) who meet the clinical and pathological diagnostic criteria outlined in the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)", have not received prior treatment, are planned to undergo target therapy, and are classified as CNLC IIb-IV stage without surgical or TACE indications. 3) Patients who have not used anti-hepatocellular carcinoma Chinese herbal medicine formulations within 2 weeks prior to the first administration, including but not limited to: Kanglait injection, Aidi or Kangsaidu injection,,,,,,,,, and, which may affect the assessment of traditional Chinese medicine efficacy. 4) Patients with an expected survival time of more than 12 weeks at the time of enrollment. 5) Patients with an ECOG PS score of 0-2 points within 1 week prior to enrollment. 6) If HBV DNA = 10^4 copies/ml, antiviral and liver-protecting treatment must be administered first, and patients can only be enrolled after HBV-DNA < 10^4 copies/ml. 7) Childbearing women must undergo a pregnancy test within 7 days prior to enrollment with a negative result, and must agree to use adequate contraceptive measures from the time of signing the informed consent form; childbearing men must agree to use adequate contraceptive measures from the time of signing the informed consent form; the timeframe is from signing the informed consent form to 3 months after the last administration of the study drug. 8) Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and agree to follow-up.
Exclusion criteria
Exclusion criteria: Complication-related exclusion criteria: 1. Clinically significant ascites, defined as ascites detected during the screening physical examination graded as 2-3 according to NCI-CTCAE v5.0, or having undergone paracentesis drainage or other treatments to reduce ascites within the 2 weeks prior to screening up to the time of screening. 2. Patients with infection-related fever, decompensated cirrhosis, upper gastrointestinal bleeding, liver failure, or decompensated cirrhosis, including those with clinically significant ascites, hepatic encephalopathy, jaundice (bilirubin > 3 times the upper limit of normal), or albumin 16 seconds or international normalized ratio (INR) = 1.5. 13. Patients with severe primary diseases of the nervous system, heart, lungs, hematopoietic system, or endocrine system, or psychiatric patients; those suspected or confirmed to have a history of alcohol or drug abuse, including uncontrolled epilepsy, Parkinson's disease, or other conditions causing significant cognitive impairment. Drug-related exclusion criteria: 1. Immunosuppressive agent use: exclusion of patients who have used high-dose immunosuppressive agents (e.g., prednisone > 10 mg/day) or other drugs affecting the immune system (e.g., cyclosporine, tacrolimus, methotrexate) within the past 3 months. 2. Anticancer drug use: exclusion of patients who have received other anticancer therapies (e.g., chemotherapy, targeted therapy, immunotherapy) within 1 month prior to enrollment. 3. Anticoagulant use: exclusion of patients requiring long-term anticoagulation therapy (e.g., warfarin, dabigatran), unless the drug can be discontinued or switched to low-molecular-weight heparin without compromising the safety of the investigational drug. 4. Participation in other clinical trials: exclusion of patients who have participated in other clinical trials within 1 month prior to scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Objective Response Rate;Disease Control Rate (DCR);Anderson Symptom Assessment Scale;TCM syndrome score;Hepatocellular carcinoma tumor markers test;Immune Microenvironment Assessment; | — |
Countries
China
Contacts
Public ContactZeng Puhua
Hunan Province Institute of Traditional Chinese Medicine
Outcome results
None listed