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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: PD-1 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04814043

B2020-411

Details and patient eligibility

About

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.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

PD-1 antibody and lenvatinib plus TACE-HAIC

Experimental group

Description:

systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion

Treatment:

Drug: PD-1 inhibitor