Actively Recruiting
Icaritin Soft Capsule Versus Huachansu Tablet in the First-line Treatment of Unresectable Hepatocellular Carcinoma With Poor Conditions and Biomarker Enrichment (Biomarker Enrichment Study of Poor Prognosis HCC Patients, BESTPOP)
Led by Beijing Shenogen Biomedical Co., Ltd · Updated on 2024-08-07
261
Participants Needed
3
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study to evaluate the efficacy and safety of icaritin versus huachansu in the first-line treatment of unresectable hepatocellular carcinoma with poor conditions and biomarker enrichment.
CONDITIONS
Official Title
Icaritin Soft Capsule Versus Huachansu Tablet in the First-line Treatment of Unresectable Hepatocellular Carcinoma With Poor Conditions and Biomarker Enrichment (Biomarker Enrichment Study of Poor Prognosis HCC Patients, BESTPOP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with hepatocellular carcinoma according to Chinese guidelines or confirmed by pathology
- Unresectable hepatocellular carcinoma
- Peripheral blood composite biomarker score of 2 or more (based on AFP, TNF-alpha, IFN-gamma levels)
- No prior first-line systemic treatment for hepatocellular carcinoma
- Child-Pugh score of 7 or less
- Adequate hematopoietic, liver, and renal function based on specified laboratory values
- If HBV-DNA is 10^4 copies/mL or higher, antiviral and liver protection therapy must be used before enrollment
- Not suitable or unwilling to receive first-line standard treatments recommended by guidelines
- Specific timing requirements after prior surgeries or local treatments
- No treatment with certain modern Chinese medicines, immunomodulators, tumor vaccines, or cellular immunotherapy within 2 weeks before randomization
- No recent blood transfusions or hematopoietic growth factors within 2 weeks before randomization
- At least one measurable lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected survival of at least 12 weeks
- Female patients of childbearing age must have a negative pregnancy test and use contraception; male patients with female partners of childbearing age must use contraception
- Voluntary informed consent and ability to comply with study requirements
- No treatment with other investigational drugs or medical devices within 4 weeks before randomization
You will not qualify if you...
- Tumor occupying 70% or more of the liver or large tumor thrombus in major veins
- Moderate to severe ascites, pleural effusion, or pericardial effusion requiring drainage
- Major surgery within 28 days before randomization or planned during the study
- Other types of primary liver cancer or recent/active other malignancies (except certain skin cancers)
- Pregnant or breastfeeding women
- Significant heart conditions including moderate to severe ischemia or heart failure
- Previous or planned allogeneic transplantation including liver transplantation
- History of hepatic encephalopathy or nephropathy within 6 months
- Positive HCV-RNA with elevated liver enzymes
- HIV antibody positive
- Severe infection at randomization
- Conditions affecting ability to swallow or absorb oral medication
- Recent or active gastrointestinal bleeding or high risk for bleeding
- Active autoimmune diseases requiring systemic treatment
- Known or suspected central nervous system metastasis
- Significant blood clotting abnormalities
- History of schizophrenia or psychiatric drug abuse
- Allergy or intolerance to study drug ingredients
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
2
Chifeng Municipal Hospital
Chifeng, Mongolia, China
Actively Recruiting
3
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
Research Team
J
Jihui Hao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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