NCT05608200

Brief Summary

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
427

participants targeted

Target at P50-P75 for phase_3

Timeline
3mo left

Started Nov 2022

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Nov 2022Oct 2026

First Submitted

Initial submission to the registry

November 2, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

November 2, 2022

Last Update Submit

May 29, 2023

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular CarcinomaLenvatinibSintilimabTransarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    The time from date of randomization to death due to any cause.

    4 years

Secondary Outcomes (5)

  • Progression free survival (PFS)

    4 years

  • Time to Progression (TTP)

    4 years

  • Objective response rate (ORR)

    4 years

  • Disease control rate (DCR)

    4 years

  • Adverse Events (AEs)

    4 years

Study Arms (2)

Len-Sin-TACE

EXPERIMENTAL

Lenvatinib, Sintilimab Plus TACE

Drug: Lenvatinib, sintilimab plus TACE

Len-TACE

ACTIVE COMPARATOR

Lenvatinib Plus TACE

Drug: Lenvatinib plus TACE

Interventions

Lenvatinib, sintilimab plus TACEDRUG

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Len-Sin-TACE
Lenvatinib plus TACEDRUG

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. The interruption, dose reduction and discontinuation of lenvatinib depended on the presence and severity of toxicities according to the drug directions.

Len-TACE

Eligibility Criteria

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

You may qualify if:

  • Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically
  • Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
  • At least one measurable intrahepatic target lesion
  • Child-Pugh class A/B
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months

You may not qualify if:

  • Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vessels
  • Vascular invasion involving inferior vena cava
  • Central nervous system metastasis
  • Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC
  • History of organ and cell transplantation
  • History of bleeding from esophageal and gastric varices
  • History of hepatic encephalopathy
  • hematologic examination: white blood cell count \<3.0×10\^9/L, platelets \<50×10\^9/L
  • Prothrombin time prolongation ≥ 4s
  • Severe organ (heart, lung, kidney) dysfunction
  • History of malignancy other than HCC
  • Active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 1000 copies/ml; hepatitis C virus (HCV) RNA \> 1000 copies/ml. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinibsintilimab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kangshun Zhu, MD

    Second Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyue Cai, MD

CONTACT

+86-20-34156205cai020@yeah.net

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

November 2, 2022

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

CN(1)