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Ate-Bev Early Response Prediction Model in Advanced HCC

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763277
Collaborator
(none)
170
Enrollment
1
Location
34
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prognosis of hepatocellular carcinoma is poor compared to other carcinomas. Many drugs have recently been developed, and recently, atezolizumab-bevacizumab treatment was superior to sorafenib, the conventional treatment for advanced hepatocellular carcinoma. However, there is no information on the evaluation on the evaluation of treatment response for atezolizumab-bevacizumab combination therapy compared to atezolizumab alone or bevacizumab alone. Therefore, this study aimed to create a predictive model that can detect treatment response at an early stage.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Early response evaluation

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
170 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Developing Atezolizumab-Bevacizumab Treatment Response Early Prediction Model in Advanced Hepatocellular Carcinoma Patients
Actual Study Start Date :
Jul 22, 2022
Anticipated Primary Completion Date :
May 22, 2024
Anticipated Study Completion Date :
May 22, 2025

Arms and Interventions

Arm Intervention/Treatment
Ate-Bev

Individuals diagnosed with advanced hepatocellular carcinoma and treated with atezolizumab-bevacizumab between the ages of 18-80 were included. According to the recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, patients with comorbidities were excluded.

Diagnostic Test: Early response evaluation
Atezolizumab and bevacizumab are administered every three weeks, and before to the second treatment cycle, blood tests and imaging tests are conducted (week 5). This precedes the standard response evaluation (week 9-12).

Outcome Measures

Primary Outcome Measures

  1. progression free survival [the follow up will be continued until June 22th 2025.]

    the index date is the date of treatment with atezolizumab and bevacizumab, and the event is either death or tumor progression of the tumor.

Secondary Outcome Measures

  1. Overall survival [the follow up will be continued until June 22th 2025.]

    the index date is the date of treatment with atezolizumab and bevacizumab, and the event is death.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patients who were diagnosed with advanced hepatocellular carcinoma and who were scheduled to receive atezolizumab-bevacizumab as the first-line therapy

  • Patients willing to participate in this study

Exclusion Criteria:

  • Individuals with a history of severe contrast allergy

  • Individuals with severe comorbidities (according to the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeong-Hoon Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05763277
Other Study ID Numbers:
  • 2206-066-1332
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Mar 10, 2023