Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy

September 15, 2021 updated by: Beijing 302 Hospital
To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Unresectable HCC patients meet surgical criteria after CK-SBRT plus TACE.

Description

Inclusion Criteria:

  • Unresectable HCC patients were diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
  • Patients who received SBRT plus TACE have tumor regression, and surgical experts assess that R0 resection could be achieved
  • CP-A or B classification;
  • Eastern Cooperative Oncology Group (ECOG) score 0-1;
  • Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
  • ICG R15≤10%;
  • Normal effective liver volume >30%;
  • patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Exclusion Criteria:

-the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after CK-SBRT plus TACE.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CK-SBRT with TACE group
Conversion hepatectomy after CK-SBRT plus TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival time
Time Frame: From date of randomization until the date of death from any cause, assessed up to 24 months.
From date of randomization until the date of death from any cause, assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival time
Time Frame: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
Radiation-induced liver injury rates
Time Frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Adverse reaction
Time Frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 10, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBRTplusTACE VS. HR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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