HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma

Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study

Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; PD-1 Inhibitor; Lenvatinib; Hepatic Arterial Infusion Chemotherapy
• Intervention / Treatment: Drug: Toripalimab; Drug: Camrelizumab; Drug: Sintilimab; Drug: Tislelizumab; Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib

Detailed Description

This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Qunfang Zhou, MD; Phone Number: 86 19868000115; Email: zhouqun988509@163.com
• Study Contact Backup: Name: Feng Duan, MD; Phone Number: 86 13910984586; Email: duanfeng@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Qunfang Zhou, MD; Phone Number: 8619868000115; Email: zhouqun988509@163.com
      • Contact: Feng Duan, MD; Phone Number: 8613910984586; Email: duanfeng@vip.sina.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.

Description

Inclusion Criteria:

1. primary infiltrative HCC according to MRI or CT imaging characteristics.
2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
3. Lenvatinib as initial treatment.
4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
5. no history of other malignancies.
6. no tumor thrombus in the atrium or vena cava.

Exclusion Criteria:

1. HCC with tumor capsule.
2. under 18 years or over 75 years.
3. TACE as initial treatment.
4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
5. incomplete tumor imaging data.
6. lost to follow-up after treatment within three months.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HAIC+Len+PD-1 inhibitor group; HAIC combined with Lenatinib and PD-1 inhibitor group	Drug: Toripalimab; 240mg intravenously every 3 weeks; Drug: Camrelizumab; 200mg intravenously every 3 weeks; Drug: Sintilimab; 200mg intravenously every 3 weeks; Drug: Tislelizumab; 200mg intravenously every 3 weeks; Procedure: Hepatic arterial infusion chemotherapy; Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.; Drug: Lenvatinib; 12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day
Len group; Lenvatinib alone	Drug: Lenvatinib; 12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	OS is the length of time from the date of inclusion until death from any cause.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free-Survival	Progression was defined as progressive disease by independent radiologic review	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.	6 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Feng Duan, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hepatic arterial infusion chemotherapy; Lenvatinib; Sintilimab; Toripalimab; Tislelizumab; Camrelizumab
• 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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Lenvatinib; Tislelizumab
• Other Study ID Numbers: Liver Project 7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No