HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

Recruiting

• Conditions: BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma; Hepatic Arterial Infusion Chemotherapy; Lenvatinib; PD-1; Systemic Therapy
• Interventions: Procedure: hepatic artery infusion chemotherapy; Drug: Lenvatinib + PD-1 monoclonal antibody

• Registration Number: NCT06632093
• Lead Sponsor: First Hospital of China Medical University

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-16
• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-06
• Last Update Submitted: 2024-10-06
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
6. Received at least 2 cycles of HAIC；
7. Has repeated measurable intrahepatic lesions;
8. Child-Pugh class A or B.

Exclusion Criteria

1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
2. With other malignant tumors;
3. Unable to meet criteria of combination timeframe described above.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HAIC plus Lenvatinib and PD-1 inhibitors	hepatic artery infusion chemotherapy	Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks.
HAIC plus Lenvatinib and PD-1 inhibitors	Lenvatinib + PD-1 monoclonal antibody	Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks.

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to approximately 2 years	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression free survival(PFS) (Overall)	Up to approximately 2 years	The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Progression free survival(PFS) of intra-hepatic lesions	Up to approximately 2 years	The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.
Progression free survival(PFS) of extra-hepatic lesions	Up to approximately 2 years	The PFS is defined as the time from the initiation of any combination treatment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.
Progression free survival(PFS) of portal vein tumor thrombus (PVTT)	Up to approximately 2 years	The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of PVTT or death due to any cause, whichever occurs first.
Objective response rate(ORR) per RESCIST 1.1	Up to approximately 2 years	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
ORR per mRECIST	Up to approximately 2 years	The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
ORR of PVTT	Up to approximately 2 years	The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0	Up to approximately 2 years	The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.

Trial Locations

Locations (1)

The first hospital of China medical university; 🇨🇳 Shenyang, Liaoning, China