NCT06333561

Brief 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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

March 21, 2024

Last Update Submit

February 5, 2025

Conditions

Hepatocellular CarcinomaLenvatinibPD-1 InhibitorHepatic Arterial Infusion Chemotherapy

Keywords

Hepatic arterial infusion chemotherapyTislelizumabToripalimabSintilimabCamrelizumabLenvatinib

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    OS is the length of time from the date of inclusion until death from any cause.

    24 months

Secondary Outcomes (1)

  • Progression-Free-Survival

    12 months

Other Outcomes (1)

  • Objective response rate

    6 months

Study Arms (2)

HAIC+Len+PD-1 inhibitor group

HAIC combined with Lenatinib and PD-1 inhibitor group

Procedure: Hepatic arterial infusion chemotherapyDrug: LenvatinibDrug: TislelizumabDrug: ToripalimabDrug: SintilimabDrug: Camrelizumab

Len group

Lenvatinib alone

Drug: Lenvatinib

Interventions

Hepatic arterial infusion chemotherapyPROCEDURE

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.

HAIC+Len+PD-1 inhibitor group
LenvatinibDRUG

12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day

HAIC+Len+PD-1 inhibitor groupLen group
TislelizumabDRUG

200mg intravenously every 3 weeks

HAIC+Len+PD-1 inhibitor group
ToripalimabDRUG

240mg intravenously every 3 weeks

HAIC+Len+PD-1 inhibitor group
SintilimabDRUG

200mg intravenously every 3 weeks

HAIC+Len+PD-1 inhibitor group
CamrelizumabDRUG

200mg intravenously every 3 weeks

HAIC+Len+PD-1 inhibitor group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinibtislelizumabtoripalimabsintilimabcamrelizumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Feng Duan, MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586duanfeng@vip.sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 27, 2024

Study Start

January 1, 2021

Primary Completion

December 30, 2024

Study Completion

December 30, 2025

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations

CN(1)