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RECRUITINGPhase 2INTERVENTIONAL

Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial

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

About This Trial

This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).

Who May Be Eligible (Plain English)

Who May Qualify: - a confirmed diagnosis of HCC - the largest intrahepatic lesion \>7 cm - presence of PVTT on imaging - tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment - Eastern Cooperative Oncology Group performance status ≤1 - Child-Pugh class A/B - adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds - expected to live at least 3 months Who Should NOT Join This Trial: - accompanied with vena cava tumor thrombus - central nervous system involvement - previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy - organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment - history of other malignancies - uncontrollable infection - history of HIV - history of organ or cells transplantation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * a confirmed diagnosis of HCC * the largest intrahepatic lesion \>7 cm * presence of PVTT on imaging * tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment * Eastern Cooperative Oncology Group performance status ≤1 * Child-Pugh class A/B * adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds * life expectancy of at least 3 months Exclusion Criteria: * accompanied with vena cava tumor thrombus * central nervous system involvement * previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy * organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment * history of other malignancies * uncontrollable infection * history of HIV * history of organ or cells transplantation

Treatments Being Tested

COMBINATION_PRODUCT

LEN+SIN+DEB-TACE+HAIC

For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE+HAIC.

COMBINATION_PRODUCT

LEN+SIN+DEB-TACE

For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE.

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China