NCT07009470进行中（未招募）不适用
A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- 2-year DFS rate and 2-year OS rate
研究概览
简要总结
For patients with early- to mid-stage hepatocellular carcinoma (HCC), the five-year postoperative recurrence and metastasis rate remains as high as 70%, significantly impacting patient prognosis.Therefore, perioperative therapy may be considered for HCC patients with these high-risk features .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent Voluntarily signed informed consent after full understanding of the study, with commitment to comply with all protocol requirements and assessment schedules.
- •Age 18-75 years inclusive.
- •Diagnosis Histologically/cytologically confirmed hepatocellular carcinoma (HCC) OR clinically diagnosed HCC per 2024 Chinese Guidelines for Primary Liver Cancer.
- •Tumor Status
- •Meets ONE of the following:
- •Multifocal tumors (2-4 lesions)
- •Single lesion >5 cm in longest diameter
- •Stage IIIa HCC with Vp1/Vp2/Vp3 portal vein tumor thrombus
- •Resectability Technically amenable to curative resection per surgeon assessment.
- •Liver Function Child-Pugh class A.
- •Performance Status ECOG PS 0-
- •Prior Therapy No previous systemic treatment for HCC.
- •Measurable Disease
- •≥1 radiologically measurable lesion per mRECIST.
- •Organ Function (1) Hematological:
- •ANC ≥1.5×10⁹/L
- •Hemoglobin ≥90 g/L
- •Platelets ≥50×10⁹/L (2) Hepatic:
- •Total bilirubin ≤1.5×ULN
- •AST/ALT ≤2.5×ULN
- •Albumin ≥28 g/L (3) Coagulation:
- •INR ≤2.3 OR PT prolongation ≤3 sec vs control (4) Renal:
- •eGFR >90 mL/min/1.73m² (CKD-EPI)
- •Contraception
- •Women of childbearing potential: Negative serum pregnancy test within 7 days prior to enrollment.
- •All subjects: Use highly effective contraception during treatment and for 180 days post-last dose.
排除标准
- •Pregnancy/Lactation Women who are pregnant or breastfeeding.
- •Concurrent Malignancy
- •History of other malignancies within 5 years except:
- •Curatively treated basal cell carcinoma
- •Cervical carcinoma in situ
- •Papillary thyroid carcinoma
- •Drug Hypersensitivity Known allergy to finolizumab, bevacizumab, or their excipients.
- •Bleeding Risk History of upper GI bleeding OR active hemorrhagic disorders.
- •Uncontrolled Cardiac Disease
- •Clinically significant cardiac conditions including:
- •NYHA Class II+ heart failure
- •Unstable angina
- •Myocardial infarction within 1 year
- •Clinically significant arrhythmias requiring intervention
- •Autoimmune Disorders Active autoimmune diseases or history of autoimmune disorders.
- •Immunodeficiency
- •Immunodeficiency conditions including:
- •HIV positive status
- •Primary/secondary immunodeficiency
- •History of organ/bone marrow transplantation
- •Psychiatric Conditions Severe psychiatric disorders OR substance abuse involving psychotropic drugs.
- •Uncontrolled Comorbidities Severe uncontrolled recurrent infections OR other significant uncontrolled comorbidities.
- •Investigator Discretion Any condition deemed ineligible by the investigator.
研究组 & 干预措施
TACE combined with targeted-immunotherapy
Experimental
干预措施: Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar) (Drug)
TACE combined with targeted-immunotherapy
Experimental
干预措施: TACE (Procedure)
结局指标
主要结局
2-year DFS rate and 2-year OS rate
时间窗: 2years
2-year DFS rate refers to the proportion of patients remaining free of disease recurrence or death for over 2 years, measured from the date of surgery. 2-year OS rate refers to the proportion of subjects surviving in the trial cohort at the 2-year follow-up mark, calculated from the initiation of neoadjuvant therapy.
次要结局
- pCR(9 weeks)
- R0 rate(9 weeks)
- EFS(2 years)
- safety(2 years)
- MPR(9 weeks)
研究者
研究点 (1)
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