HAIC in Combination with PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

Recruiting

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

• Registration Number: NCT06631326
• 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 high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-16
• Study First Submitted: 2024-10-05
• Study First Submitted QC: 2024-10-05
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

1. Age 18 to 80 years old;
2. Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
5. Presence of PVTT;
6. Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
7. Child-Pugh class A or B7;
8. Tumor burden meets up to 7 out criteria.

Exclusion Criteria

1. Patients who took anti-tumor treatments before the combination therapy;
2. With other malignant tumors;
3. incomplete data.

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, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months.
HAIC plus Lenvatinib and PD-1 inhibitors	Lenvatinib + PD-1 monoclonal antibody	Each patient should receive at least 2 cycles of HAIC, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months.
Lenvatinib plus PD-1 inhibitors	Lenvatinib + PD-1 monoclonal antibody	Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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