NCT04387695

Brief Summary

To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.

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
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2020

Typical duration for phase_3

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

Study Start

First participant enrolled

April 30, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

3.3 years

First QC Date

May 11, 2020

Last Update Submit

February 14, 2023

Conditions

Unresectable Hepatocellular CarcinomaPortal Vein Thrombosis

Keywords

Hepatocellular Carcinoma,Portal Vein Tumor ThrombusRadiation ,Sorafenib

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS) rate

    Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.

    at 12 weeks after randomization

Secondary Outcomes (4)

  • Radiologic response rate

    at 12 weeks after randomization

  • Overall patient survival rate

    up to 2 years after randomization

  • Objective response rate

    at 12 weeks and up to 2 years after randomization

  • Disease control rate

    at 12 weeks and up to 2 years after randomization

Study Arms (2)

SBRT + TACE + Sorafenib

EXPERIMENTAL

SBRT sequential TACE combined with Sorafenib

Radiation: SBRT+TACE+Sorafenib

Sorafenib

ACTIVE COMPARATOR

Sorafenib 800 mg/day orally

Drug: Sorafenib

Interventions

SBRT+TACE+SorafenibRADIATION

SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later

Also known as: Stereotactic Body Radiation Therapy
SBRT + TACE + Sorafenib
SorafenibDRUG

Sorafenib 800 mg/day orally

Also known as: Nexavar
Sorafenib

Eligibility Criteria

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

You may qualify if:

  • Age \>18 years
  • Child-Pugh score ≤ 7
  • Performance status: ECOG score ≤ 2
  • HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
  • the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
  • No previous therapy for HCC
  • at least one measurable target lesion according to RECIST 1.1
  • Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
  • Serum total bilirubin ≤ 2 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
  • Creatinine ≤ 1.5 x ULN
  • No plan for pregnancy or breast feeding. Active contraception.
  • Willing to give informed consent

You may not qualify if:

  • Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
  • Complete obstruction of hepatic outflow
  • Uncontrolled ascites of hepatic encephalopathy
  • Prior liver transplantation
  • Positive for human immunodeficiency virus (HIV)
  • Active gastric or duodenal ulcer
  • Other uncontrolled comorbidities or malignancy
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

RadiosurgerySorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesPhenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jun-hui Sun, MD,PH.D

    First Affiliated Hospital of Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Jun-hui Sun, MD,PH.D

CONTACT

+86-0571-872368151307005@zju.edu.cn

Tan-yang Zhou, MD,PH.D

CONTACT

+86-0571-87236812zhoutanyang@zju.edu.cn

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

May 11, 2020

First Posted

May 14, 2020

Study Start

April 30, 2020

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)