NCT05992584

Brief Summary

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
3mo left

Started Aug 2023

Typical duration for phase_2 hepatocellular-carcinoma

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 Progress93%
Aug 2023Aug 2026

First Submitted

Initial submission to the registry

August 7, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2026

Expected
Last Updated

September 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

August 7, 2023

Last Update Submit

September 12, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaLenvatinibSintilimabYttrium-90

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS) according to mRECIST

    The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

    2.5 years

Secondary Outcomes (5)

  • Progression free survival (PFS) according to RECIST 1.1

    2.5 years

  • Objective response rate (ORR)

    2.5 years

  • Disease control rate (DCR)

    2.5 years

  • Overall survival (OS)

    2.5 years

  • Adverse Events (AEs)

    2.5 years

Study Arms (1)

Len-Sin-SIRT

EXPERIMENTAL

Lenvatinib, sintilimab plus SIRT

Drug: Lenvatinib, sintilimab plus SIRT

Interventions

Lenvatinib, sintilimab plus SIRTDRUG

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 SIRT. 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-SIRT

Eligibility Criteria

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

You may qualify if:

  • Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
  • At least one measurable untreated lesion
  • Intrahepatic tumors can be treated with 1-2 session of SIRT
  • Child-Pugh score 5-7
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Life expectancy of at least 3 months
  • Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
  • Patients with hepatitis C need to finish the anti-HCV treatment

You may not qualify if:

  • tumor extent ≥70% liver occupation
  • Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
  • Vena cava invasion
  • Central nervous system metastasis
  • Metastatic disease that involves major airways or blood vessels
  • Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
  • History of organ and cell transplantation
  • Prior esophageal and/or gastric varices bleeding
  • History of hepatic encephalopathy
  • Peripheral blood white blood cell count\<3×10\^9/L, platelet count\<50×10\^9/L
  • Prolongation of prothrombin time ≥ 4 seconds
  • Severe organ dysfunction (heart, lungs, kidneys)
  • History of malignancy other than HCC
  • HBsAg and anti-HCV antibody positive concurrently
  • Human immunodeficiency virus (HIV) infected

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

lenvatinibsintilimabSirtuins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Group III Histone DeacetylasesHistone DeacetylasesAmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesADP Ribose TransferasesPentosyltransferasesGlycosyltransferasesTransferasesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205zhksh010@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

August 10, 2023

Primary Completion

January 9, 2026

Study Completion (Estimated)

August 9, 2026

Last Updated

September 14, 2023

Record last verified: 2023-08

Locations

CN(1)