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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333561
• Other study ID #: Liver Project 7
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Qunfang Zhou, MD
• Phone: 86 19868000115
• Email: zhouqun988509[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Lenvatinib

Intervention

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
• Tislelizumab
200mg intravenously every 3 weeks
• Toripalimab
240mg intravenously every 3 weeks
• Sintilimab
200mg intravenously every 3 weeks
• Camrelizumab
200mg intravenously every 3 weeks

Locations

Country	Name	City	State
China	Chinese PLA General hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Overall survival	OS is the length of time from the date of inclusion until death from any cause.	24 months
Secondary	Progression-Free-Survival	Progression was defined as progressive disease by independent radiologic review	12 months