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Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo

ConditionResectable Hepatocellular Carcinoma With High Risk of Recurrence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed Informed Consent Form available

Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form

Diagnosis of HCC confirmed by histology

Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size >5 cm, tumor number >3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1/Vp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).

Disqualifiers

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC

Clinically diagnosed hepatic encephalopathy in the last 6 months

Autoimmune hepatitis (requiring liver puncture)

History of organ transplantation

Trial design

Design model

Single group

Treatments tested in this trial

  • Atezolizumab

    Drug

    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

  • Bevacizumab

    Drug

    Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.

  • Transarterial chemoembolization (TACE)

    Procedure/Surgery

    TACE will be performed by clinical demand.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Atezolizumab + Bevacizumab + TACEExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathologic Complete Response (pCR) Rate

pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.

Time frame
At the time of surgery

Secondary outcomes

1

Major Pathologic Response (MPR) Rate

MPR rate is defined as the proportion of participants with =\<30% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review.

Time frame
At the time of surgery
2

Relapse-Free Survival (RFS)

RFS is defined as the time from surgery to the first documented recurrence of disease (intrahepatic or extrahepatic) according to EASL and/or RECIST v1.1, or death from any cause.

Time frame
Surgery to the first documented recurrence of disease (up to approximately 2 years)
3

Event-Free Survival (EFS)

EFS is defined as the time from enrollment to any of the following events (whichever occurs first): disease progression that precludes surgery, as assessed by the investigator according RECIST v1.1; local regional, or distant disease recurrence as measured by EASL and/or RECIST v1.1; or death from any cause.

Time frame
Enrollment up to approximately 2 years
4

Overall Survival (OS)

OS is defined as the time from enrollment to death from any cause.

Time frame
Enrollment to death from any cause (up to approximately 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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