Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma (A-BEST)

October 30, 2024 updated by: Hwa Kyung Byun, Yonsei University

Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma

To determine the efficacy and safety of atezolizumab-bevacizumab combination therapy plus stereotactic body radiotherapy(SBRT) in patients with advanced hepatocellular carcinoma, Subjects will start SBRT for one or more primary cancers and/or metastatic lesions and no more than 5 sites within two month before and after the start date of atezolizumab-bevacizumab combination therapy.

In this study, it is expected to improve the treatment response rate of atezolizumab-bevacizumab therapy, which is currently first-line chemotherapy but has a low treatment response rate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The subjects with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and if they voluntarily agree to the clinical trial after explanation of the clinical trial, they are included in the clinical trial. Subjects should begin SBRT(stereotactic body radiotherapy) to one or more but not more than five sites for primary cancer and/or metastatic lesions within two month before and after the start date of atezolizumab-bevacizumab combination therapy.

The followings are evaluation items for each visit.

Visit 1 (-6~0 weeks) ± 7days *Screening

  • Informed consent form
  • Inclusion Criteria/ Exclusion Criteria
  • Medical history and physical examination
  • Staging via CT, MRI, PET-CT, etc. (PET-CT examination is not compulsory)
  • CBC, SMA, PT/aPTT, Tumor markers, Biomarkers
  • Stool microbiota NGS
  • QoL Questionnaire(EORTC-QLQ-C30 V3)

Visit 2 (0~7 weeks) ± 7 days *During SBRT

  • Confirmation of adverse events
  • QoL Questionnaire(EORTC-QLQ-C30 V3)

Visit 3 (1~8 weeks) *1 week after SBRT

  • Confirmation of adverse events
  • CBC, SMA, PT/aPTT, Tumor markers, Biomarkers
  • QoL Questionnaire(EORTC-QLQ-C30 V3)

Visit 4 (6~9 weeks) ± 7 days *After 2 cycles of chemotherapy

  • Confirmation of adverse events
  • CBC, SMA, PT/aPTT, Tumor markers, Biomarkers
  • Stool microbiota NGS
  • QoL Questionnaire(EORTC-QLQ-C30 V3)

Visit: 5~12 (3~36 months) ± 2 weeks *Follow-up

  • Confirmation of adverse events
  • Evaluation of effectiveness* (Imaging tests, Tumor markers, CBC, SMA, PT/aPTT are performed according to the need)
  • QoL Questionnaire(EORTC-QLQ-C30 V3)

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

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

  • Name: Hwakyung BYUN, Phd
  • Phone Number: 007981072098955
  • Email: hkbyun05@yuhs.ac

Study Locations

  • Korea, Republic of
      • Yongin-si, Korea, Republic of, 365
        • Recruiting
        • Yongin Severance Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 19 to 80 years old
  2. Liver function Child-Pugh class A
  3. ECOG 0-1
  4. Patient clinically or pathologically diagnosed with hepatocellular carcinoma
  5. Advanced hepatocellular carcinoma that is inoperable
  6. Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy.

Exclusion Criteria:

  1. Brain metastases
  2. Have a history of malignancy other than hepatocellular carcinoma within the last 5 years (except for malignancies with little risk of metastasis or death, e.g., adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, tubular carcinoma in situ, or stage 1 uterine cancer.)
  3. Subjects with a high probability of untreated gastric or esophageal varices or bleeding
  4. Serious uncontrolled medical comorbidities
  5. History of liver transplant surgery
  6. Autoimmune liver disease

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with advanced hepatocellular carcinoma
Patients indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and those voluntarily agree to the clinical trial after explanation of the study, are enrolled in the study.
Radiation: Stereotactic body radiotherapy
Patients with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and they should begin stereotactic radiotherapy to one or more but not more than five sites for primary cancer and/or metastatic lesions within two month before and after the start date of atezolizumab-bevacizumab combination therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival at 6 month
Time Frame: 6 months after registration
The primary endpoint is to improve 6-month progression-free survival rate in the treatment group compared to those existing literature. Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
6 months after registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months after registration
Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
36 months after registration
Objective response rate
Time Frame: 36 months after registration
Objective response rate will be ratepresented as a proportion of the total.
36 months after registration
Adverse event (Toxicity)
Time Frame: 36 months after registration
Toxicity will be evaluated using CTCAE version 5.0 and presented as a proportion of the total.
36 months after registration
Tumor marker response: AFP, PIVKA-II
Time Frame: 36 months after registration
Tumor markers and biological markers are descriptive as statistics such as mean, standard deviation, and median for continuous data will be presented, and changes in values before and after treatment will be compared and evaluated using paired t-test or Wilcoxon signed rank test.
36 months after registration

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hwakyung BYUN, Phd, Severance 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 (Actual)

May 28, 2024

Primary Completion (Estimated)

April 25, 2027

Study Completion (Estimated)

March 27, 2028

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-2024-0026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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