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

NCT06632093 | Recruiting

• 1 other identifier: CHANCE2417
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma; Hepatic Arterial Infusion Chemotherapy; Lenvatinib; PD-1; Systemic Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Progression free survival(PFS) (Overall)

  Up to approximately 2 years

• Progression free survival(PFS) of intra-hepatic lesions

  Up to approximately 2 years

• Progression free survival(PFS) of extra-hepatic lesions

  Up to approximately 2 years

• Progression free survival(PFS) of portal vein tumor thrombus (PVTT)

  Up to approximately 2 years

• Objective response rate(ORR) per RESCIST 1.1

  Up to approximately 2 years

Study Arms (1)

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; Drug: Lenvatinib + PD-1 monoclonal antibody

Interventions

hepatic artery infusion chemotherapy PROCEDURE

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

HAIC plus Lenvatinib and PD-1 inhibitors

Lenvatinib + PD-1 monoclonal antibody DRUG

PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

HAIC plus Lenvatinib and PD-1 inhibitors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

The first hospital of China medical university

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Interventions

lenvatinib

Central Study Contacts

Jiaxi Liu

CONTACT

+8618940279150; dmuvictor@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: September 16, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

CN (1)