Single-Center, Prospective, Single-Arm Clinical Study Protocol of Icaritin Soft Capsules as Adjuvant Therapy for Hepatocellular Carcinoma With High-Risk Recurrence Factors Post-Resection
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- RFS
研究概览
简要总结
Observing the Efficacy and Safety of Icaritin Soft Capsules as Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Patients with High-Risk Factors for Recurrence (A Single-Arm, Single-Center, Prospective Clinical Study Protocol)
Detailed Description:
Primary Endpoint:
Recurrence-Free Survival (RFS)
Secondary Endpoints:
Recurrence-Free Survival Rate (RFSR) at 6 months and 12 months, Overall Survival (OS) , Quality of Life (QoL) , Safety (including incidence and severity of Adverse Events [AEs] and Serious Adverse Events [SAEs]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Clinically or histologically/cytologically confirmed hepatocellular carcinoma (HCC) per the Primary Liver Cancer Diagnosis and Treatment Guidelines (2022 Edition). Archived tissue samples are permitted; if no prior histological diagnosis exists, fresh tumor biopsy must be performed at baseline.
- •At least one measurable lesion (RECIST v1.1).
- •Child-Pugh score ≤
- •Patients who underwent R0 resection (postoperative pathology report required) and showed no residual intrahepatic lesions on MRI within 8 weeks after surgery.
- •At least one high-risk recurrence factor:
- •Tumor size ≥ 5 cm;
- •Tumor number ≥ 3;
- •Microvascular invasion (MVI) grade: M1 or M2;
- •Portal vein tumor thrombus resection (Cheng's classification I or II).
- •No prior systemic therapy for HCC.
- •Normal major organ function, with laboratory results meeting the following
- •criteria within 7 days before treatment:
- •Hemoglobin > 80 g/L;
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
- •Platelet count ≥ 40 × 10⁹/L;
- •Serum albumin ≥ 28 g/L;
- •Total bilirubin ≤ 2 × upper limit of normal (ULN);
- •AST/ALT ≤ 5 × ULN;
- •Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
- •Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min.
- •Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN or prothrombin time (PT) ≤ 16 s.
- •Ability to swallow and absorb oral medication.
- •Negative serum pregnancy test within 7 days before randomization for women of childbearing potential; agreement to use effective contraception during treatment and for 60 days after the last dose.
- •Voluntary participation with signed informed consent and expected good compliance.
排除标准
- •Prior systemic therapy for HCC, including chemotherapy, targeted agents (e.g., sorafenib, lenvatinib, regorafenib), immune modulators (anti-PD-1/PD-L1/CTLA-4), or modern Chinese medicine with antitumor indications. Concurrent use of any investigational drug (except antiviral therapy) is excluded.
- •Recurrent or metastatic HCC.
- •Clinically significant ascites, pleural effusion, or pericardial effusion uncontrolled by medication at enrollment.
- •(Note: Imaging-detected ascites without clinical symptoms is permitted.)
- •History of abdominal wall fistula, gastrointestinal perforation, refractory unhealed gastric ulcer, or active gastrointestinal bleeding within 6 months before enrollment.
- •HCC lesion(s) ≥ 10 cm in any dimension (confirmed by BICR), > 10 lesions, or HCC volume ≥ 50% of liver volume; macrovascular portal vein tumor thrombosis.
- •Major cardiovascular impairment within 12 months before treatment:
- •NYHA Class II+ heart failure;
- •Unstable angina, myocardial infarction, or stroke;
- •Arrhythmia with hemodynamic instability;
- •QTc interval > 480 ms.
- •Any surgery within 28 days before the first dose.
- •History or current diagnosis of coagulopathy, bleeding, or thrombotic disorders.
- •Clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis, decompensated cirrhosis, severe fatty liver, hereditary liver disease, liver atrophy, superior vena cava syndrome, or portal hypertension.
- •(Note: Portal hypertension without ascites, jaundice, or gastrointestinal bleeding may be considered.)
- •Active autoimmune disease requiring systemic therapy within the past 2 years.
- •Live vaccine administered within 30 days before the first dose.
- •Hypersensitivity to any component of Epimedium Soft Capsules.
- •Uncontrolled active HBV, HCV, or HDV infection; active tuberculosis.
- •Pregnancy, lactation, or unwillingness to use contraception during the study.
- •Any condition that may contraindicate the study drug, compromise data reliability, increase treatment risk, or affect compliance (e.g., metabolic disorders, abnormal lab results).
- •Investigator judgement of unsuitability for the study.
研究组 & 干预措施
Study Cohort
Within 8 weeks after R0 resection for hepatocellular carcinoma, patients begin adjuvant therapy with Icaritin Soft Capsules until disease recurrence, with treatment duration not exceeding 1 year. Icaritin Soft Capsules are administered orally at 600 mg twice daily, taken within 30 minutes after morning and evening meals with warm water. If a dose is missed and cannot be taken within 2 hours after a meal, patients should skip the missed dose and resume the next scheduled dose without make-up administration.
干预措施: Icaritin soft capsules (Drug)
结局指标
主要结局
RFS
时间窗: Follow-up will be conducted for up to 1 year, from baseline through study completion, with imaging assessments performed at protocol-defined intervals.
For eligible subjects meeting all inclusion/exclusion criteria, study-related data collection will commence within 8 weeks after hepatocellular carcinoma resection. Enrolled patients will enter the treatment phase and receive Icaritin Soft Capsules as postoperative adjuvant therapy. Following treatment initiation, contrast-enhanced CT or MRI will be performed every 3 months (±7 days) to evaluate hepatic lesions and detect potential recurrence or metastasis.
次要结局
未报告次要终点