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 | Recruiting Phase 3 DMC

• 1 other identifier: SNG2111-ICR-1
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 3

Brief 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

Hepatocellular Carcinoma

Keywords

Icaritin, Poor Conditions, Composite Biomarker; First-line Treatment

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Defined as the time from randomization to death from any cause

  From randomization to death from any cause, assessed up to approximately 24 months

Secondary Outcomes (10)

• 9/12/18-month overall survival (OS) rate

  From randomization to 9, 12 and 18 months later

• Time to progression (TTP)

  From randomization to the first occurrence of disease progression, assessed up to approximately 24 months

• Progression--free survival (PFS)

  From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), assessed up to approximately 24 months

• Objective response rate (ORR)

  Up to approximately 24 months after randomization

• Disease control rate (DCR)

  Up to approximately 24 months after randomization

Study Arms (2)

Icaritin soft capsule

EXPERIMENTAL

Drug: Icaritin

Huachansu tablet

ACTIVE COMPARATOR

Drug: Huachansu

Interventions

Icaritin DRUG

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 soft capsule

Huachansu DRUG

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 tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years and older;
• HCC patients who meet the clinical diagnostic criteria of the Chinese Diagnosis and Treatment Guideline of Primary Liver Cancer (2022 edition), and/or with diagnosis confirmed histopathologically/cytologically;
• Unresectable HCC patients;
• Patients with a peripheral blood composite biomarker Score ≥ 2 points, 1 point each for AFP ≥ 400 ng/mL, TNF-α \< 2.5 pg/mL, and IFN-γ ≥ 7.0 pg/mL ;
• 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;
• Child-Pugh score ≤ 7;
• Vital organ functions should meet the following requirements:
• ① Hematopoietic function: platelet ≥ 40×10\^9/L, hemoglobin ≥ 80 g/L, white blood cell ≥ 2.0×10\^9/L;
• ② 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;
• ③ Renal function: Serum Creatinine ≤ 1.5×ULN, or creatinine clearance rate ≥ 50 mL/min;
• If HBV-DNA ≥ 10\^4 copies/mL (2000 IU/mL), antiviral and liver protection therapy must be used before enrollment, until HBV-DNA \< 10\^4 copies/mL (2000 IU/mL). In which case, the antiviral drugs should be administered continuously and liver function and hepatitis B virus load will be monitored during the study period;
• Patients who meet one of two conditions: (A) are not or less appropriate candidates for first-line standard treatments recommended by the guidelines; (B) are not willing to receive first-line standard treatments recommended by the guidelines.
• Surgical resection ended \> 3 months, local ablation, hepatic artery intervention or radiotherapy ended \> 4 weeks before randomization (implantation of radioactive particles ended \> 3 months) and relevant adverse reactions having recovered. Patients without extrahepatic spread must have radiographic evidence of disease progression after local treatment;
• Patients who had previously received adjuvant systemic therapy after surgical resection experienced the first radiographic disease progression more than 6 months after withdrawal of adjuvant therapy will be eligible for enrollment;
• No blood transfusion or infusion of blood products, no use of hematopoietic growth factors (such as granulocyte colony-stimulating factor G-CSF), and no albumin infusion within 2 weeks prior to randomization;

You may not qualify if:

• Tumor occupancy ≥ 70% of liver, or tumor thrombus occupancy ≥ 50% of the main trunk of portal vein, or mesenteric vein or inferior vena cava tumor thrombus;
• Moderate-to-severe ascites, i.e., the score of the indicator is \> 2; Moderate-to-severe, or symptomatic pleural effusion and pericardial effusion requiring drainage;
• Receipt of major surgery (craniotomy, thoracotomy, laparotomy, hip replacement, etc.) within 28 days prior to randomization or planned to receive major surgery during the study;
• Other types of primary liver cancer, such as intrahepatic cholangiocarcinoma, mixed HCC and cholangiocarcinoma, fibrolamellar HCC, etc. Other malignancies within 5 years prior to signing the informed consent form or at present, excluding radically treated basal cell carcinoma of skin, squamous cell carcinoma of skin and/or radically resected carcinoma in situ;
• Pregnant or lactating women;
• Grade 2 or above myocardial ischemia or myocardial infarction (NCI-CTCAE v5.0), poorly-controlled arrhythmia, and/or New York Heart Association (NYHA) class III or IV cardiac insufficiency;
• Patients who previously received allogeneic transplantation including liver transplantation, or plan to undergo liver transplantation during the study;
• History of hepatic encephalopathy and/or hepatic nephropathy within 6 months prior to signing informed consent ;
• HCV-RNA positive, ALT and/or AST \> 2×ULN;
• Human immunodeficiency virus (HIV) antibody positive;
• Severe infection (≥ Grade 3 of NCI-CTCAE v5.0 criteria) at randomization;
• Unable to swallow, chronic diarrhea or intestinal obstruction, which will significantly affect oral administration and absorption of the study drug;
• History of gastrointestinal hemorrhage within 6 months before signing informed consent, or with clear tendency for gastrointestinal hemorrhage at present, such as: local active ulcers, stool occult blood ≥ 2+ or positive at two consecutive tests (attention should be paid to exclude the influence of food, drugs and other diseases);
• Active autoimmune diseases requiring systemic treatment (e.g., NSAIDs, immunosuppressants, biologics, corticosteroids, etc.) except for patients receiving replacement therapy (e.g., hypothyroidism treated with thyroxine, type 1 diabetes mellitus treated with insulin, adrenal or pituitary insufficiency treated with physiologic corticosteroids, etc.);
• Significant coagulation function abnormalities: international standardized ratio (INR) \> 1.5 or prothrombin time (PT) \> 16 s;

Sponsors & Collaborators

• Beijing Shenogen Biomedical Co., Ltd: lead

Study Sites (3)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Chifeng Municipal Hospital

Chifeng, Mongolia, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

icaritin; huachansu

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jihui Hao, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihui Hao, MD

CONTACT

022-23340123; haojihui@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 26, 2022
• Study Start: December 12, 2022
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)