TACE-HAIC Plus Lenvatinib for Patients With Unresectable HCC: an Open-label, Single-arm, Phase 2 Trial

NCT04531228 | Unknown

• 1 other identifier: B2020-137
• Study Type: interventional
• Target: 60
• 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, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for early-stage and well reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of unresectable HCC. TACE has been proved to provide outstanding efficacy for treating advanced stage HCC patients. However, TACE is associated with a high rate of treatment failure for advanced HCC patients. EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate in our previous study. Levatinib is a new treatment and offers relative high overall response rate for advanced HCC, which was approved in China and Japan. However, whether the combination of TACE-HAIC and Lenvatinib would increse tumor control for unresectable patients is still unknown. Thus, this single arm, phase 2 study is designed to analyze the safety and efficacy TACE-HAIC plus Lenvatinib for patients with unresectalbe HCC.

Conditions

Hepatocellular Carcinoma; Transarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  the time from assignment to progression, death or last follow-up.

  6-12 months

Secondary Outcomes (3)

• overall survival

  6-12 months

• overall response rate

  6-12 months

• adverse effects

  6-12 months

Study Arms (1)

Experimental: TACE-HAIC plus lenvatinib

EXPERIMENTAL

chemo-lipiodolization, followed by FOLFOX-based chemotherapy artery infusion (HAIC). Lenvatinib was administrated two or four days after TACE-HAIC.

Procedure: TACE-HAIC plus lenvatinib

Interventions

TACE-HAIC plus lenvatinib PROCEDURE

chemo-lipiodolization with EADM (30mg/m2), followed by FOLFOX-based chemotherapy artery infusion (Oxa 85mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2). Lenvatinib was administrated two or four days after TACE-HAIC, with 8mg for patients weight \<60kg, or 12mg for patients weight more than 60Kg.

Experimental: TACE-HAIC plus lenvatinib

Eligibility Criteria

• Age: 17 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
• unresectable disease, stage BCLC B/C
• 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

Sponsors & Collaborators

• Yunfei Yuan: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

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

Central Study Contacts

Jiliang Qiu

CONTACT

+862087342654; qiujl@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: October 11, 2020
• Primary Completion: April 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)