NCT05994859

Brief Summary

This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
10mo left

Started Aug 2023

Typical duration for not_applicable 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 Progress78%
Aug 2023Feb 2027

First Submitted

Initial submission to the registry

August 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2027

Last Updated

September 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 9, 2023

Last Update Submit

September 12, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinomaunresectableselective internal radiation therapy

Outcome Measures

Primary Outcomes (1)

  • Success rate of conversion to resection

    The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT

    3 years

Secondary Outcomes (7)

  • Objective response rate (ORR)

    3 years

  • Disease control rate (DCR)

    3 years

  • Progression-free survival (PFS)

    3 years

  • Time to progression (TTP)

    3 years

  • Duration of response (DOR)

    3 years

  • +2 more secondary outcomes

Study Arms (1)

SIRT

EXPERIMENTAL

Treatment with SIRT.

Procedure: SIRT

Interventions

SIRTPROCEDURE

The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.

SIRT

Eligibility Criteria

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

You may qualify if:

  • HCC with diagnosis confirmed pathologically or clinically
  • No pervious treatment for HCC
  • At least one measurable intrahepatic target lesion
  • Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein
  • Disease amenable to SIRT (after evaluation)
  • Child-Pugh Class A or without cirrhosis
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • 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
  • Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, white blood cell count \>3.0×10\^9/L, absolute value of neutrophils \>1.5×10\^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range
  • Life expectancy of at least 6 months

You may not qualify if:

  • Tumor involving main portal vein, bilateral branches of portal vein, or vena cava
  • tumor extention beyond one lobe of the liver
  • Bilobar tumor distribution
  • Extrahepatic metastasis
  • Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy
  • Organ (heart, kidney) dysfunction
  • HBsAg and anti-HCV antibody positive concurrently
  • History of malignancy other than HCC
  • Uncontrolled infection
  • History of HIV
  • History of organ and cell transplantation
  • Patients with bleeding tendency

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

Sirtuins

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
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

August 10, 2023

Primary Completion (Estimated)

August 9, 2026

Study Completion (Estimated)

February 9, 2027

Last Updated

September 14, 2023

Record last verified: 2023-08

Locations

CN(1)