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Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

Sponsor
Yonsei University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05908916
Collaborator
(none)
51
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.

Condition or Disease Intervention/Treatment Phase
  • Drug: AtezoBev with combined radiotherapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapeutic arm

AtezoBev with combined radiotherapy

Drug: AtezoBev with combined radiotherapy
Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle with 3-week intervals, and additional radiotherapy (iGTV 50-60 Gy, CTV 40Gy, PTV 30Gy / 10Fx) for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [2 years (per 9 weeks)]

    Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. age ≥19;

  2. clinically or histologically diagnosed HCC;

  3. HCC with Vp2-Vp4 portal vein invasion;

  4. intact liver function with Child-Pugh class A;

  5. adequate size of RT field;

  6. intact performance with ECOG below 2;

  7. non-pregnant with acceptable contraception in premenopausal women);

  8. without other life-threatening diseases;

  9. ability to provide written informed consent and to comply with all study conditions.

Exclusion Criteria:

  1. Active uncontrolled infection;

  2. Current or history (< or = 5 years) of advanced malignancies in the other organs;

  3. History of liver transplantation;

  4. miliary HCC which incompatible external beam RT

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Do Young Kim, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT05908916
Other Study ID Numbers:
  • 4-2023-0384
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jun 18, 2023