這是一項III期、隨機、開放標籤、贊助商盲試驗、3組、多中心、全球性研究，評估rilvegostomig合併貝伐單抗± tremelimumab與atezolizumab合併貝伐單抗的療效和安全性。本研究將在不適合治療或局部區域治療的晚期HCC參與者中進行
適應症：Hepatocellular Carcinoma
收案條件
納入條件
- Locally advanced or metastatic and/or unresectable HCC
- WHO/ECOG performance status of 0 or 1
- BCLC stage B (that is not eligible for locoregional therapy) or stage C.
- Child-Pugh Score class A
- At least one measurable target lesion
- Participants with active HBV infection must receive antiviral therapy for a minimum of 14 days prior to randomization to show evidence of HBV stabilization or signs of viral response.
- Participants with active HCV infection must be well controlled. Participants co-infected with HBV and HCV are not eligible.
- Adequate organ and bone marrow function measured during the screening period.
- Adequate organ and bone marrow function measured during the screening period
- Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.
- Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.
排除條件
- Medical condition
- Any evidence of uncontrolled intercurrent diseases
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
- History of another primary malignancy
- Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.
- History of active primary immunodeficiency or active infection
- History of hepatic encephalopathy
- Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible
- History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 6 months prior to study randomization.
- Participants with untreated or incompletely treated varices with bleeding or high-risk (red wale signs or other high-risk factors) for bleeding.
- HCC related
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
- Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
- Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。