CompletedPhase 2

DYNAmic Immune Microenvironment of HCC Treated With atezolIzumab Plus bevaCizumab

South Korea40 participantsStarted 2021-10-29

Plain-language summary

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).

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Acquisition of Signed Informed Consent Form prior to any study specific procedures * Willingness and ability to comply with the study protocol * ≥ 19 years of age at the time of signing Informed Consent Form * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 * Histologically or cytologically confirmed HCC * Child-Pugh class A (Child-Pugh score of 5 or 6) assessed within 7 days * Negative HIV test at screening * Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test * For patients with active hepatitis B virus (HBV): HBV DNA \< 500 IU/mL obtained within 28 days prior to initiation of study treatment, and Anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study * Potentially resectable Barcelona Clinic Liver Cancer (BCLC) stage B/C meeting any of the following criteria by 4-phase liver dynamic computed tomography (CT) or gadoxetic-acid enhanced magnetic resonance imaging (MRI) or chest CT with enhancement * Portal vein invasion (Vp1, Vp2 and Vp3) * Hepatic vein invasion (Vv1 and Vv2) * Lymph node metastasis * multiple tumor nodules (n ≥ 2) * Solitary distant metastasis or Resectable HCC meeting any of the following criteria by 4-phase liver dynamic CT or gadoxetic-acid enhanced MRI * Serum alpha-feto protein (AFP) level of ≥ 400ng/mL * Largest tumor diameter of ≥ 5cm * Presence of s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The rate of major pathological response

Timeframe: Through treatment discontinuation, an average of 6 months

Distinct immunophenotypes and dynamic changes of tumor-infiltrating immune cells by single nucelar RNA-sequencing, single cell RNA sequencing, spatial transcriptomics, multiplexed immunohistochemistry (mIHC), flow cytometry (and/or CyTOF)

Timeframe: up to 36 months

Trial details

NCT IDNCT04954339

SponsorTae Won Kim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-10

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials