NCT06707233

Brief Summary

This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
19mo left

Started Dec 2024

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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 Progress48%
Dec 2024Nov 2027

First Submitted

Initial submission to the registry

November 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

November 24, 2024

Last Update Submit

January 26, 2025

Conditions

Hepatocellular Carcinoma Non-Resectable

Keywords

Hepatocellular Carcinomayttrium-90selective internal radiation therapy

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR) per mRECIST

    The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST

    3 years

Secondary Outcomes (7)

  • Objective response rate (ORR) per RECIST 1.1

    3 years

  • Disease control rate (DCR)

    3 years

  • Progression free survival (PFS)

    3 years

  • time to response (TTR)

    3 years

  • Duration of response (DOR)

    3 years

  • +2 more secondary outcomes

Study Arms (1)

SIRT

EXPERIMENTAL

Patients will receive SIRT treatment

Procedure: SIRT

Interventions

SIRTPROCEDURE

The patients will receive 1-2 sessions of SIRT.

SIRT

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed or clinically diagnosed HCC
  • Unresectable HCC as assessed by a team of surgeons
  • The largest tumor size \> 7 cm
  • Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
  • At least one measurable intrahepatic target lesion
  • Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
  • Child-Pugh score ≤ 7
  • ECOG PS ≤ 1
  • Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
  • life expectancy of at least 6 months

You may not qualify if:

  • Macrovascular invasion or extrahepatic metastasis
  • Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
  • Organ (heart and kidneys) dysfunction
  • History of other malignancies
  • Uncontrollable infection
  • History of organ or cells transplantation
  • History of HIV
  • Pregnant or lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

NOT YET RECRUITING

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

Study Record Dates

First Submitted

November 24, 2024

First Posted

November 27, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2027

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

CN(2)