招募中 NCT06921785

Rilvegostomig与Bevacizumab合并或不合并Tremelimumab作为肝细胞癌一线治疗的III期研究

肝癌胆道癌肉瘤Phase IIIIII 期IV 期

这是一项III期、随机、开放标签、赞助商盲试验、3组、多中心、全球性研究,评估rilvegostomig合并贝伐单抗± tremelimumab与atezolizumab合并贝伐单抗的疗效和安全性。本研究将在不适合治疗或局部区域治疗的晚期HCC参与者中进行

适应症:Hepatocellular Carcinoma

入组条件

纳入标准

  • 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.

排除标准

  • 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

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。