NCT05250843

Brief Summary

The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

February 15, 2022

Last Update Submit

October 11, 2023

Conditions

Hepatocellular Carcinoma

Keywords

LenvatinibTACEPD-1

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival

    Time from the start of liver resection until tumor recurrence or death (from any cause).

    12 months

Secondary Outcomes (1)

  • Adverse effects

    12 months

Study Arms (2)

TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection

EXPERIMENTAL

For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection

Procedure: TACE/HAICDrug: LenvatinibDrug: Sintilimab

Direct surgery group

ACTIVE COMPARATOR

After being diagnosed with hepatocellular carcinoma, surgery will be immediately performed.

Procedure: liver resection

Interventions

TACE/HAICPROCEDURE

Within 1-3 days of lenvatinib and sintilimab, start Transarterial chemobolization treatment or FOLFOX-based chemotherapy infusion,after three months,patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection.

TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
LenvatinibDRUG

Participants received lenvatinib capsules 8mg for patients weight \<60kg, or 12mg for patients weight more than 60Kg.

TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
SintilimabDRUG

Sintilimab Injection will be administered every three weeks (200mg) until surgery or disease progression.

TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
liver resectionPROCEDURE

liver resection is feasible after evaluation by the liver cancer surgery expert group

Direct surgery group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Age 18-70 years old, gender is not limited.
  • )The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
  • )Patients must have at least one tumor lesion that can be accurately measured.
  • )Conform to any of the following criteria (1) multiple nodules \>3; (2) ≥2 nodules, any of which is \>3 cm; (3) invasion of the portal vein or hepatic vein.
  • )According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group
  • )No previous anti-HCC treatment.
  • )Eastern Co-operative Group performance status 2 or less.
  • )Liver function: Child's A or B (score \< 7).

You may not qualify if:

  • )Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava;
  • \) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs;
  • \) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinibsintilimabHepatectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctorate

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 22, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)