NCT05594927

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (estimated)
• Sponsor: Beijing Shenogen Biomedical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, parallel-controlled, double-blind, double-dummy, multicenter, phase III clinical trial. Patients with poor conditions and biomarker enrichment will be randomly assigned in a 2:1 ratio to receive either icaritin or huachansu as the first-line treatment until unacceptable toxic effects and loss of clinical benefit. A total of 261 participants with 206 deaths are required. The primary endpoint is overall survival (OS) in the full analysis set (FAS) population.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-12
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2022-10-26
• Last updated: 2024-08-07

Locations

3 sites across 1 country: China