MedTrace Logo

Atezolizumab, Bevacizumab, and Tocilizumab in Advanced Hepatocellular Carcinoma

NCT07774247 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-08-19

No results posted yet for this study

Summary

This is a Phase 2, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of atezolizumab, bevacizumab, and tocilizumab in patients with locally advanced, metastatic, and/or unresectable hepatocellular carcinoma (HCC). Approximately 51 patients will be enrolled at 6 study sites and will receive combination therapy consisting of atezolizumab, bevacizumab, and tocilizumab. Patients assigned to the study will receive atezolizumab 1,200 mg intravenously and bevacizumab 15 mg/kg intravenously on Day 1 of each 21-day cycle, alongside tocilizumab 4 mg/kg intravenously on Day 1 of each 42-day cycle for up to 5 doses. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The study population includes adult patients with locally advanced, metastatic, and/or unresectable HCC who have received no prior systemic therapy for hepatocellular carcinoma. Eligible patients must have histologically, cytologically, or radiologically confirmed diagnosis, at least one measurable lesion according to RECIST version 1.1, Child-Pugh class A liver function, ECOG performance status 0 or 1, and adequate organ function. The primary objective is to assess the incidence of Grade 3 or higher immune-related adverse events (irAEs) occurring within 24 weeks after treatment initiation according to NCI CTCAE version 5.0. Secondary objectives include evaluation of objective response rate (ORR) and disease control rate (DCR) according to RECIST v1.1, progression-free survival, overall survival, and the rate of treatment discontinuation due to adverse events. Safety evaluations will include assessment of adverse events, serious adverse events, laboratory parameters, vital signs, and other clinical assessments. Exploratory objectives include evaluation of the correlation between treatment response and serum inflammatory markers (such as IL-6 and CRP) and immune cell profiles using blood samples collected at protocol-defined intervals. Tumor assessments will be performed at protocol-defined intervals using radiologic imaging every 6 weeks from Cycle 1 Day 1 up to Week 54, and every 9 weeks thereafter. The primary efficacy analysis will be based on the Full Analysis Set according to RECIST v1.1. This study is intended to evaluate the clinical activity and safety profile of prophylactic tocilizumab in combination with atezolizumab and bevacizumab in this patient population and to generate data to inform future clinical development.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Atezolizumab

Atezolizumab will be administered intravenously at a fixed dose of 1,200 mg on Day 1 of each 21-day cycle. The initial infusion will be administered over 60 (±5) minutes. Subsequent infusions may be administered over 30 (±5) minutes if well tolerated, or 60 (±5) minutes if infusion-related reactions occurred previously.

DRUG

Bevacizumab

Bevacizumab will be administered intravenously at a dose of 15 mg/kg on Day 1 of each 21-day cycle. The initial infusion will be administered over 90 (±5) minutes. If well tolerated, the second infusion may be administered over 60 (±5) minutes, and subsequent infusions over 30 (±5) minutes. Bevacizumab must be administered at least 5 minutes after completion of atezolizumab infusion. Bevacizumab should be administered ≥3 days after biopsy and only after adequate wound healing is confirmed.

DRUG

Tocilizumab

Tocilizumab will be administered intravenously at a dose of 4 mg/kg over at least 60 minutes on Day 1 of each 42-day cycle, for up to 5 doses. On C1D1, tocilizumab will be administered at least 60 minutes after completion of bevacizumab infusion. In subsequent cycles, if the previous bevacizumab infusion was well tolerated without premedication, tocilizumab may be administered ≥30 minutes after bevacizumab. If infusion-related reactions occurred, tocilizumab must be administered ≥60 minutes after bevacizumab.

Sponsors & Collaborators

  • CHA University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2029-09-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774247 on ClinicalTrials.gov