NCT07684040尚未招募2 期
A Prospective Single-arm Clinical Study Evaluating the Efficacy and Safety of Hepatic Resection After Initial Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab Plus Rivoceranib in Patients With Initially Resectable Hepatocellular Carcinoma
Affiliated Hospital of Guangdong Medical University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Time to Treatment Failure
研究概览
简要总结
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of an initial combination treatment strategy followed by surgery in patients with cancer. Eligible participants will receive combination therapy prior to surgical intervention. Patients who meet predefined surgical criteria will undergo hepatic resection. Following surgery, additional treatment may be administered according to the investigator's assessment. The primary objective is to evaluate time to treatment failure (TTF). Secondary objectives include evaluation of pathological response, resection outcomes, progression-related outcomes, survival outcomes, and safety.
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
- •1. Voluntarily signed written informed consent.
- •2. Age ≥18 years; male or female.
- •3. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) according to EASL/AASLD criteria.
- •4. CNLC stage Ib, IIa, IIb, or IIIa HCC (excluding patients with main portal vein tumor thrombus).
- •5. Presence of vascular invasion and no extrahepatic metastasis, including PVTT (Vp1-Vp3), HVTT, or IVCTT.
- •6. No prior systemic treatment for HCC, including chemotherapy, targeted therapy, or immunotherapy.
- •7. Child-Pugh class A liver function.
- •8. ECOG performance status 0-
- •9. Adequate organ function:
- •ANC ≥1.5 × 10^9/L; Platelet count ≥75 × 10^9/L; Hemoglobin ≥90 g/L.
- •Albumin ≥30 g/L; Total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance >50 mL/min.
- •INR ≤2.3 or PT prolongation ≤6 seconds.
- •Urine protein <2+; if ≥2+, 24-hour urine protein <1.0 g.
- •10. For patients with active HBV infection, effective antiviral therapy is required, with HBV DNA ≤2000 IU/mL or a ≥10-fold reduction after antiviral treatment.
- •11. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after study completion. Male participants must also use effective contraception during the study and for 6 months after study completion.
排除标准
- •1. Intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, fibrolamellar carcinoma, or any other active malignancy within the past 5 years (except HCC).
- •2. Severe allergy to iodinated contrast agents that prevents HAIC treatment.
- •3. Planned or prior organ transplantation or allogeneic bone marrow transplantation.
- •4. Treatment with another investigational drug within 28 days before study treatment.
- •5. Current or prior central nervous system metastases.
- •6. History of hepatic encephalopathy.
- •7. Current interstitial pneumonitis or interstitial lung disease.
- •8. Active autoimmune disease or history of autoimmune disease with risk of recurrence.
- •9. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before study treatment.
- •10. Severe infection within 4 weeks before study treatment.
- •11. Gastrointestinal bleeding within 6 months before study treatment or a known risk of gastrointestinal bleeding.
- •12. Known hereditary or acquired bleeding disorders or thrombotic tendency.
- •13. Uncontrolled clinically significant cardiac disease or symptoms.
- •14. Moderate or severe ascites requiring therapeutic drainage or paracentesis.
- •15. Major vascular disease within 6 months before study treatment.
- •16. Inability to swallow oral medication, malabsorption syndrome, or any condition affecting gastrointestinal absorption.
- •17. Known hypersensitivity to any study drug, its excipients, monoclonal antibodies, or anti-angiogenic agents.
- •18. Any other serious acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase study risk, interfere with study results, or make the patient unsuitable for participation.
结局指标
主要结局
Time to Treatment Failure
时间窗: 24 months
Time from initiation of treatment to treatment failure, including disease progression resulting in inability to undergo surgery, recurrence/metastasis after surgery, or death from any cause.
次要结局
- OS(24 months)
- R0 rate(24 months)
- pCR rate(24 months)
- ORR(24 months)
研究者
研究点 (1)
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