PD-1 Antibody and Lenvatinib Plus TACE-HAIC for Potential Resectable HCC: a Single-arm Phase 2 Clinical Trial

  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    Sun Yat-sen University
Updated on 30 September 2021


Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, less than 20% of newly diagnosed patients can undergo radical resection. Our latest study showed that 48% potentially resectable HCC received hepatectomy after transarterial chemoembolization plus FOLFOX-based chemotherapy infusion (TACE-HAIC) treatment. Recently, several clinical trials (LEAP-002) showed that PD-1 antibody and Lenvatinib had an ORR of 36% for advanced patients. The combination of TACE-HAIC with PD-1 antibody and lenvatinib, theoretically can significantly decrease the tumor burden and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to investigate TACE-HAIC plus PD-1 antibody and Lenvatinib will increase the resection rate for those patients.

Condition HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Liver Cancer, Adenocarcinoma, liver cell carcinoma, Malignant Adenoma
Treatment PD-1 Inhibitor
Clinical Study IdentifierNCT04814043
SponsorSun Yat-sen University
Last Modified on30 September 2021


Yes No Not Sure

Inclusion Criteria

Diagnosed as potentially resectable with consensus by the panel of liver surgeons
stage BCLC A/B/C, without extra-hepatic involvement
No previous anti-HCC treatment
Eastern Co-operative Group performance status 2 or less
Liver function: Child's A or B (score < 7)

Exclusion Criteria

Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
underlying serve cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial
Patients ineligible for hepatic artery embolization, or PD-1 antibody
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