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

NCT04814043 | Unknown Phase 2

• 1 other identifier: B2020-411
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• conversion rate to resection

  The conversion rate to resection among all the enrolled patients

  12 month

Study Arms (1)

PD-1 antibody and lenvatinib plus TACE-HAIC

EXPERIMENTAL

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

Drug: PD-1 inhibitor

Interventions

PD-1 inhibitor DRUG

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

Also known as: lenvatinib, TACE-HAIC

PD-1 antibody and lenvatinib plus TACE-HAIC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immune Checkpoint Inhibitors; lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Yunfei Yuan

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiliang Qiu

CONTACT

+862087343114; qiujl@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: systemic PD-1 antibody and lenvatinib plus TACE-HAIC for potential resectable HCC

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 24, 2021
• Study Start: April 20, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)