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)
NCT05594927 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261
Last updated 2024-08-07
Summary
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
Interventions
- DRUG
-
Icaritin
600 mg (6 x 100 mg capsules) icaritin administered orally twice daily (30 minutes after breakfast and dinner, respectively) until treatment discontinuation criteria are met.
- DRUG
-
Huachansu
1200 mg (4 x 300 mg tablets) huachansu administered orally three times a day (30 minutes after breakfast, lunch and dinner, respectively) until treatment discontinuation criteria are met.
Sponsors & Collaborators
-
Beijing Shenogen Biomedical Co., Ltd
lead INDUSTRY
Principal Investigators
-
Jihui Hao, MD · Tianjin Medical University Cancer Institute and Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-12
- Primary Completion
- 2025-08-30
- Completion
- 2025-08-30
Countries
- China
Study Locations
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