Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

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.

Icaritin

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.

Huachansu

Jihui Hao, MD

JianBin Wu, Doctor

Hongbo Ji, Doctor

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.

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.

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)

Defined as the time from randomization to death from any cause

Defined as the percentage of participants who are alive at 9, 12, 18 months following randomization

Defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator and IRC according to RECIST v1.1

Defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator and IRC according to RECIST v1.1

Defined as the percentage of participants with complete response (CR) or partial response (PR), as determined by the investigator and IRC according to RECIST v1.1

Defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD), as determined by the investigator and IRC according to RECIST v1.1

Defined as the time from randomization to first deterioration, i.e., decrease or increase from baseline of ≥ 10 points in the following EORTC QLQ-C30 and EORTC QLQ-HCC18 subscales respectively, maintained for two consecutive assessments or one assessment followed by death from any cause within 4 weeks:

Defined as all untoward medical events in a participant administered the study drug, which can be symptoms, signs, diseases or laboratory abnormalities, irrespective of the causality with the study drug.

The type, incidence, severity, and relationship with study drugs of adverse events (AEs) will be evaluated.

Defined as trough plasma concentration（Cmin）of icaritin and its metabolites

Defined as maximum plasma concentration (Cmax) of icaritin and its metabolites

Defined as Mean area under the concentration-time curve during the dosing interval (AUC0-t) of icaritin and its metabolites at steady state

Spots Global Cancer Trial Database for icaritin, poor conditions, composite biomarker