DYNAmic Immune Microenvironment of HCC Treated With atezolIzumab Plus bevaCizumab

Sponsor
Tae Won Kim
Study ID
NCT04954339
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Aatezolizumab plus Bevacizumab — DRUG
    Two cycles of naeoadjuvant atezolizumab (1200 mg) plus bevacizumab (15 mg/kg) prior to surgical resection and four cycles of adjuvant atezolizumab (1200 mg) plus bevacizumab (15 mg/kg) after the surgery will be administered.

Study Details

Part I (Clinical trial setting): A single-arm phase II study to investigate the efficacy of neoadjuvant atezolizumab (T) + bevacizumab (A) in patients with potentially resectable BCLC stage B/C or high risk resectable hepatocellular carcinoma (HCC) (n = 40) Part II (Biomarker study setting): Exploratory translational research will be conducted using samples obtained from Part 1 (n =40) and those acquired from an independent cohort of treatment-naïve HCC patients (n = 15).

Key Dates

Start date
Oct 29, 2021
Status verified
Jun 2026
Primary completion
Oct 10, 2025
Completion
May 26, 2026

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab plus Bevacizumab
    Two cycles of naeoadjuvant atezolizumab (1200 mg) plus bevacizumab (15 mg/kg) prior to surgical resection and four cycles of adjuvant atezolizumab (1200 mg) plus bevacizumab (15 mg/kg) after the surgery will be administered.

Primary Outcome Measure

The rate of major pathological response [ Time Frame: Through treatment discontinuation, an average of 6 months ]

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