NCT06435013

Brief Summary

Previous studies had suggested hepatic arterial infusion chemotherapy (HAIC) combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (HCC). Two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors \[lenvatinib\] and anti-VEGF antibody \[bevacizumab\]) were applied in first-line treatment of unresectable HCC. However, little is known about the difference of efficacy and safety between lenvatinib (LenHAP) or bevacizumab (BevHAP) combined with ICIs and HAIC in unresectable HCC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 24, 2024

Last Update Submit

May 24, 2024

Conditions

Hepatocellular CarcinomaLenvatinib

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    2015-1 to 2023-4

Study Arms (2)

LenHAP

Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;

Drug: Lenvatinib

BevHAP

Bevacizumab combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;

Interventions

LenvatinibDRUG

Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;

LenHAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with received the combination therapy of lenvatinib/bevacizumab, hepatic arterial infusion chemotherapy and PD-1/L1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ming Shi

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 30, 2024

Study Start

December 1, 2023

Primary Completion

March 1, 2024

Study Completion

May 20, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)