这是一项第二期、单臂、多中心研究,评估durvalumab及tremelimumab联合lenvatinib在不可切除HCC参与者中的疗效及安全性。
适应症:Hepatocellular Carcinoma
入组条件
纳入标准
- Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
- Must not have received prior systemic therapy for unresectable HCC.
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- Child-Pugh Score class A.
- ECOG performance status of 0 or 1 at enrollment.
- At least 1 measurable lesion per RECSIT 1.1 guidelines
排除标准
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
- History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
- Clinically meaningful ascites.
- Patients with main portal vein thrombosis.
- Active or prior documented GI bleeding.
- Patient currently exhibits symptomatic or uncontrolled hypertension.
- Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
- Uncontrolled intercurrent illness
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。