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

NCT ID: NCT04814043

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2023-12-30

Brief 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 antibody and lenvatinib plus TACE-HAIC

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

Group Type: EXPERIMENTAL

PD-1 inhibitor

Intervention Type: DRUG

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

Interventions

PD-1 inhibitor

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

Intervention Type: DRUG

Other Intervention Names

lenvatinib; TACE-HAIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yunfei Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunfei Yuan

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiliang Qiu

Role: CONTACT

qiujl@sysucc.org.cn

+862087343114

Facility Contacts

Jiliang Qiu

Role: primary

qiujl@sysucc.org.cn

+862087342651

Other Identifiers

B2020-411

Identifier Type: -

Identifier Source: org_study_id