REPLACE 是一項第三期、多中心、隨機、開放標籤試驗，旨在評估 regorafenib 與 pembrolizumab（Rego-Pembro）對比經動脈化療栓塞（TACE）或經動脈放射栓塞（TARE）用於肝細胞癌（HCC 或肝癌）第一線治療的療效與安全性。
適應症：Carcinoma, Hepatocellular
收案條件
納入條件
- Signed and dated Patient Informed Consent Form (PICF)
- ≥ 18 years-old at the time of PICF signature
- Confirmed diagnosis of HCC
- Intermediate-stage HCC, defined as follows:
- Multinodular HCC localized to the liver
- No evidence of MVI or EHS
- Not amenable to curative treatment
- Child-Pugh Class A
- ECOG PS 0 or 1
- ALBI grade 1 or 2
- Beyond up-to-seven criteria
- Disease amenable to TACE or TARE and no contradiction to intra-arterial treatment
- Measurable disease by CT or MRI as per RECIST 1.1
- No prior systemic therapy or loco-regional therapy for HCC
- Adequate hematologic and organ function
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
- Women of childbearing potential (CBP) must have confirmed negative serum pregnancy test
- Use of highly-effective contraceptive methods in women of CBP and men
- Patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) infection are eligible if they meet criteria as defined within the protocol
排除條件
- No measurable tumor of a diffuse infiltrative HCC type.
- Fibrolamellar HCC, sarcomatoid HCC or mixed hepatocellular/ cholangiocarcinoma subtypes.
- Clinically meaningful ascites.
- Prior treatment with regorafenib, a PD-1, PD-L1/PD-L2, or cytotoxic T lymphocyte associated protein 4 (CTLA-4) inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization.
- Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids.
- Requirement of systemic treatment with either corticosteroids or other immunosuppressive medications ≤ 14 days prior to randomization.
- Interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, or clinically significant acute lung diseases.
- Cardiovascular conditions as defined within the protocol.
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed ≤ 2 years before randomization.
- Persistent proteinuria of NCI-CTCAE v5.0 Grade 3.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
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。