Atezolizumab, Bevacizumab, and Tocilizumab in Advanced Hepatocellular Carcinoma

Sponsor
CHA University
Study ID
NCT07774247
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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.
  • Bevacizumab — DRUG
    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.
  • Tocilizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2029

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Bevacizumab + Tocilizumab
    Patients will receive atezolizumab 1,200 mg intravenously on Day 1 of each 21-day cycle and bevacizumab 15 mg/kg intravenously on Day 1 of each 21-day cycle, administered until disease progression, unacceptable toxicity, or a maximum duration of 2 years. In addition, patients will receive prophylactic tocilizumab 4 mg/kg intravenously on Day 1 of each 42-day cycle (every 6 weeks) for up to a maximum of 5 doses.

Primary Outcome Measure

Incidence of grade ≥3 immune-related adverse events (irAEs) within 24 weeks after treatment initiation [ Time Frame: Within 24 weeks after treatment initiation. ]

Central Contacts

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