The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD

ConditionHCC - Hepatocellular Carcinoma

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorEastern Hepatobiliary Surgery Hospital

About this trial

This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ECOG performance status of 0-1

Preoperative imaging diagnosis of advanced hepatocellular carcinoma (BCLC stage C or D, unsuitable for surgery)

Ultrasound or MRI indicating moderate to severe fatty liver (Fibroscan CAP > 268 dB/m or MR fat score > 10%)

Willing to use contraceptive measures during the trial period

Disqualifiers

Excessive alcohol consumption (weekly ethanol intake: males < 210 g, females < 140 g)

Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy

Pregnant or breastfeeding women, or positive pregnancy test at baseline

Central nervous system metastases diagnosed by CT, MRI, or PET-CT

Trial design

Design model

Parallel

Treatments tested in this trial

Sequential treatment of bevacizumab combined with atezolizumab (sequential group)
Drug
The first cycle (3 weeks) receives bevacizumab monotherapy, and from the second cycle onwards, it is combined with atezolizumab until disease progression or intolerable toxicity.
Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)
Drug
Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Sequential treatment of bevacizumab combined with atezolizumab (sequential group)Experimental treatment 1 intervention

Group B: Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

objective response rate (ORR)

Compare the objective response rate (ORR) of sequential treatment with bevacizumab combined with atezolizumab (sequential group) and concurrent treatment (concurrent group) in advanced HCC under MASLD background, according to RECIST 1.1 criteria.

Time frame

6 Months

Sponsors and contacts

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

Eastern Hepatobiliary Surgery Hospital

Lead sponsor

Source ClinicalTrials.gov

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