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

Sun Yat-sen University Cancer Center

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Transarterial Chemoembolization
• Intervention / Treatment: Procedure: TACE-HAIC plus lenvatinib

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiliang Qiu; Phone Number: +862087342654; Email: qiujl@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: TACE-HAIC plus lenvatinib; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	the time from assignment to progression, death or last follow-up.	6-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	the time from assignment to death or last follow-up	6-12 months
overall response rate	Objective response rate defined as confirmed complete response or partial response under mRECIST 1.1 criteria	6-12 months
adverse effects	Frequency and severity of adverse effects as defined by CTCAE version 5	6-12 months

Collaborators and Investigators

• Sponsor: Yunfei Yuan

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2020
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: B2020-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No