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

Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Jiaxi Liu; Phone Number: +8618940279150; Email: dmuvictor@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: Haibo Shao; Phone Number: +8618940279150; Email: dmuvictor@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with intermediate or advanced HCC who have failed in systemic therapy recommended by BCLC and received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HAIC plus Lenvatinib and PD-1 inhibitors; 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.	Procedure: hepatic artery infusion chemotherapy; Hepatic arterial infusion chemotherapy including FOLFOX and RALOX; Drug: Lenvatinib + PD-1 monoclonal antibody; PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate(ORR) per RESCIST 1.1	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.	Up to approximately 2 years
ORR of PVTT	The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.	Up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0	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.	Up to approximately 2 years
Progression free survival(PFS) (Overall)	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.	Up to approximately 2 years
Progression free survival(PFS) of intra-hepatic lesions	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.	Up to approximately 2 years
Progression free survival(PFS) of extra-hepatic lesions	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.	Up to approximately 2 years
Progression free survival(PFS) of portal vein tumor thrombus (PVTT)	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.	Up to approximately 2 years
ORR per mRECIST	The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Protein Kinase Inhibitors; Antibodies; Antibodies, Monoclonal; Lenvatinib
• Other Study ID Numbers: CHANCE2417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No