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OncoMatch/Clinical Trials/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)

Is NCT05594927 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Icaritin and Huachansu for hepatocellular carcinoma.

Phase 3RecruitingBeijing Shenogen Biomedical Co., LtdNCT05594927Data as of May 2026

Treatment: Icaritin · HuachansuA 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy (sorafenib, lenvatinib, donafenib, atezolizumab plus bevacizumab, sintilimab plus a bevacizumab biosimilar, camrelizumab plus apatinib, durvalumab plus tremelimumab, oxaliplatin-based systemic chemotherapy (FOLFOX4), icaritin, huachansu)

No prior first-line systemic treatment for HCC, including sorafenib, lenvatinib, donafenib, atezolizumab plus bevacizumab, sintilimab plus a bevacizumab biosimilar, camrelizumab plus apatinib, and durvalumab plus tremelimumab, oxaliplatin-based systemic chemotherapy (FOLFOX4), icaritin, huachansu, and other anti-cancer drugs such as targeted agents, immune checkpoint inhibitors, and systemic chemotherapy

Lab requirements

Blood counts

platelet ≥ 40×10^9/L, hemoglobin ≥ 80 g/L, white blood cell ≥ 2.0×10^9/L

Kidney function

Serum Creatinine ≤ 1.5x ULN, or creatinine clearance rate ≥ 50 mL/min

Liver function

total bilirubin ≤ 1.5x ULN, ALT and AST ≤ 5x ULN, albumin ≥ 28 g/L, Child-Pugh score ≤ 7

Vital organ functions should meet the following requirements: Hematopoietic function: platelet ≥ 40×10^9/L, hemoglobin ≥ 80 g/L, white blood cell ≥ 2.0×10^9/L; Liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN), alanine Aminotransferase (ALT) and aspartate Aminotransferase (AST) ≤ 5×ULN; albumin ≥ 28 g/L; Child-Pugh score ≤ 7; Renal function: Serum Creatinine ≤ 1.5×ULN, or creatinine clearance rate ≥ 50 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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