Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

This study aims to evaluate the safety and effectiveness of a combined treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The treatment includes transarterial chemoembolization (TACE), which delivers chemotherapy directly into the liver tumor, together with low-dose bevacizumab and atezolizumab, two medicines that help the immune system fight cancer and inhibit tumor blood vessel growth.

All participants in this study will receive the same combination treatment as their first-line therapy. The study will observe how well the tumor responds, how long the treatment can control the cancer, and what side effects may occur. The goal is to learn whether this combined approach can provide clinical benefit and improve outcomes for patients with advanced, unresectable liver cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between18 and 75 years;

Has a diagnosis of HCC confirmed by radiology, histology, or cytology;

Child-Pugh class A;

Eastern Cooperative Group performance status (ECOG) score of 0-1;

Disqualifiers

Diffuse HCC;

Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;

Evidence of extrahepatic spread (EHS);

Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;

Trial design

Design model

Single group

Treatments tested in this trial

  • Transarterial chemoembolization (TACE)

    Procedure/Surgery

    The intervention consisted of TACE combined with low-dose bevacizumab and atezolizumab. TACE was performed within 30 days before or after systemic therapy. The choice between conventional TACE and DEB-TACE was determined by interventional radiologists, as both techniques show comparable efficacy. For DEB-TACE, epirubicin-loaded microspheres were used; for conventional TACE, an epirubicin-lipiodol emulsion was prepared. In all cases, the tumor-feeding artery was super-selectively catheterized, and embolization was performed to complete arterial stasis using gelatin sponge particles. Following TACE-induced ischemic and cytotoxic tumor control, patients received systemic therapy consisting of low-dose bevacizumab to attenuate post-TACE angiogenic rebound and atezolizumab to enhance antitumor immune activation. This sequential combination of locoregional therapy and dual-agent systemic therapy constitutes a distinct intervention compared with standard TACE or systemic therapy alone.

  • bevacizumab and atezolizumab

    Drug

    Low dose bevacizumab and atezolizumab

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TACE + LDBev + AtezoExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time from randomization to death from any cause.

Time frame
2 years

Secondary outcomes

1

Progression free survival (PFS)

Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.

Time frame
2 years

Other outcomes

1

Objective response rate (ORR)

The percentage of patients who had a best overall tumor response rating of CR and PR (mRECIST).

Time frame
2 years

Locations

This trial has no locations.

Sponsors and contacts

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