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

Not Applicable

• Conditions: Transarterial Chemoembolization; Hepatocellular Carcinoma
• Interventions: Procedure: TACE-HAIC plus lenvatinib

• Registration Number: NCT04531228
• Lead Sponsor: Yunfei Yuan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Study Start: 2020-10-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-22
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: TACE-HAIC plus lenvatinib	TACE-HAIC plus lenvatinib	chemo-lipiodolization, followed by FOLFOX-based chemotherapy artery infusion (HAIC). Lenvatinib was administrated two or four days after TACE-HAIC.

Primary Outcome Measures

Name	Time	Method
progression-free survival	6-12 months	the time from assignment to progression, death or last follow-up.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China