BridgeMD
Compares treatment options for Hepatocellular Carcinoma
Official title 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)
ClinicalTrials.gov ID: NCT05594927
What this study is testing
What is Icaritin?
Icaritin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)...
- 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...
You likely can't join 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...
- Moderate-to-severe ascites, i.e., the score of the indicator is \> 2; Moderate-to-severe, or symptomatic pleural effusion and pericardial effusion...
- Receipt of major surgery (craniotomy, thoracotomy, laparotomy, hip replacement, etc.) within 28 days prior to randomization or planned to receive...
- Other types of primary liver cancer, such as intrahepatic cholangiocarcinoma, mixed HCC and cholangiocarcinoma, fibrolamellar HCC, etc. Other...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Within 2 weeks prior to randomization, no treatment with modern Chinese traditional medicine preparations with anti-tumor indications (refer to the 11th inclusion criterion when huaier granule was used as systemic...
- 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;
- ≥1 measurable lesion according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1), defined as a non-lymphoid lesion with the longest diameter ≥ 10 mm or a lymph node lesion with the short axis ≥ 15 mm; a...
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1;
- Expected survival of ≥ 12 weeks;
- Female patients of childbearing age with a negative blood pregnancy within the first 7 days prior to randomization will be eligible; Female patients of childbearing age or male patients with female sexual partners of...
- Voluntary agreement to sign informed consent and the willingness and ability to comply with protocol schedules and testing;
- No treatment with any other investigational drugs or medical devices within 4 weeks prior to randomization.
- 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...
- 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...
- Active autoimmune diseases requiring systemic treatment (e.g., NSAIDs, immunosuppressants, biologics, corticosteroids, etc.) except for patients receiving replacement therapy (e.g., hypothyroidism treated with...
- Known central nervous system (CNS) metastasis; patients suspected of CNS metastasis need to undergo cerebral MRI/CT for exclusion;
- Significant coagulation function abnormalities: international standardized ratio (INR) \> 1.5 or prothrombin time (PT) \> 16 s;
- History of schizophrenia or psychiatric drug abuse;
- Known allergy or intolerance to any ingredients of icaritin or huachansu preparations;
- Other conditions that the investigator considers inappropriate for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
- Chifeng, Mongolia, China
- Tianjin, Tianjin Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China; Chifeng, Mongolia, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.