RecruitingPhase 3NCT05594927

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)

A Prospective, Randomized, Parallel-Controlled, Double-Blind, Double-Dummy, Multicenter, Phase III Clinical Trial of 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)


Sponsor

Beijing Shenogen Biomedical Co., Ltd

Enrollment

261 participants

Start Date

Dec 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two traditional Chinese medicines — Icaritin soft capsules and Huachansu tablets — as first-line treatments for people with liver cancer (hepatocellular carcinoma) that cannot be surgically removed and has poor prognostic biomarkers. The goal is to find which is more effective in this specific patient group. **You may be eligible if...** - You are 18 years or older with confirmed liver cancer that cannot be surgically removed - You have specific blood biomarker levels (high AFP, low TNF-α, high IFN-γ) that match the study criteria - You have not previously received any systemic treatment for liver cancer **You may NOT be eligible if...** - Your tumor takes up more than 70% of your liver - You have moderate-to-severe fluid buildup in the abdomen (ascites) or around the lungs - You have had major surgery recently - You have other serious liver, kidney, or heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIcaritin

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.

DRUGHuachansu

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.


Locations(3)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Chifeng Municipal Hospital

Chifeng, Mongolia, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

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NCT05594927


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