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RECRUITINGPhase 2INTERVENTIONAL

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 18 years or older. 2. HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria. 3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system. 4. A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm. 5. No prior treatment for HCC. 6. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). 7. Performance status (PS) ECOG score ≤1. 8. Child-Pugh score ≤7. 9. Subjects voluntarily participate in this study, and sign the willing to sign a consent form form, cooperate with the follow-up 10. your organs (liver, kidneys, etc.) are working well enough based on blood tests, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 \^ 9/L; PLT ≥ 75 x 10 \^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal. Who Should NOT Join This Trial: 1. Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type; 2. Previous liver transplantation; 3. History of other malignancies; 4. Previous history of severe mental illness; 5. Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion; 6. Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy; 7. Other reasons were judged by the investigator to be unable to enroll. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 18 years or older. 2. HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria. 3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system. 4. A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm. 5. No prior treatment for HCC. 6. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). 7. Performance status (PS) ECOG score ≤1. 8. Child-Pugh score ≤7. 9. Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up 10. Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 \^ 9/L; PLT ≥ 75 x 10 \^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal. Exclusion Criteria: 1. Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type; 2. Previous liver transplantation; 3. History of other malignancies; 4. Previous history of severe mental illness; 5. Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion; 6. Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy; 7. Other reasons were judged by the investigator to be unable to enroll.

Treatments Being Tested

DRUG

Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC

RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Tislelizumab

Locations (1)

Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China