Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

NCT05908916 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 4-2023-0384
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  2 years (per 9 weeks)

Study Arms (1)

Therapeutic arm

EXPERIMENTAL

AtezoBev with combined radiotherapy

Drug: AtezoBev with combined radiotherapy

Interventions

AtezoBev with combined radiotherapy DRUG

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.

Therapeutic arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥19;
• clinically or histologically diagnosed HCC;
• HCC with Vp2-Vp4 portal vein invasion;
• intact liver function with Child-Pugh class A;
• adequate size of RT field;
• intact performance with ECOG below 2;
• non-pregnant with acceptable contraception in premenopausal women);
• without other life-threatening diseases;
• ability to provide written informed consent and to comply with all study conditions.

You may not qualify if:

• Active uncontrolled infection;
• Current or history (\< or = 5 years) of advanced malignancies in the other organs;
• History of liver transplantation;
• miliary HCC which incompatible external beam RT

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Do Young Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Do Young Kim

CONTACT

82-2-2228-1992; dyk1025@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)