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

Hepatocellular Carcinoma Clinical Trial

— Thalen  

Official title:

Sun Yat-sen University Cancer Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531228
• Other study ID #: B2020-137
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: Jiliang Qiu
• Phone: +862087342654
• 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 18-75 years

1. The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)

2. unresectable disease, stage BCLC B/C

3. No previous anti-HCC treatment

4. Eastern Co-operative Group performance status 2 or less

5. Liver function: Child's A or B (score < 7)

Exclusion Criteria:

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

1. underlying serve cardiac or renal diseases

2. Known or suspected allergy to the investigational agent or any agent given in association with this trial

3. Patients ineligible for hepatic artery embolization

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Transarterial Chemoembolization

Intervention

Procedure:
• TACE-HAIC plus lenvatinib
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yunfei Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	the time from assignment to progression, death or last follow-up.	6-12 months
Secondary	overall survival	the time from assignment to death or last follow-up	6-12 months
Secondary	overall response rate	Objective response rate defined as confirmed complete response or partial response under mRECIST 1.1 criteria	6-12 months
Secondary	adverse effects	Frequency and severity of adverse effects as defined by CTCAE version 5	6-12 months