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

Hepatocellular Carcinoma Clinical Trial

— PLATIC  

Official title:

Systemic PD-1 Antibody (Sintilimab) and Lenvatinib Plus Transarterial Chemoembolization and FOLFOX-based Chemotherapy Infusion for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04814043
• Other study ID #: B2020-411
• Status: Recruiting
• Phase: Phase 2
• Start date: April 20, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: Jiliang Qiu
• Phone: +862087343114
• Email: qiujl[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conversion rate to resection	The conversion rate to resection among all the enrolled patients	12 month