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NCT Number: NCT06323382

Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma

Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 inhibitor as standard of care in hopes of answering key clinical questions.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
  • age between 18 and 75 years;
  • Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage).
  • Locoregional therapy include TACE or HAIC, locoregional combined with Bevacizumab and PD1/L1 inhibitor as firstline therapy; non-firstline therapy (previous use of any systemic therapy but intolerant or drug resistant).
  • Child-Pugh class A or B;
  • Eastern Cooperative Group performance status (ECOG) score of 0-2;
  • Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
  • Prothrombin time ≤18s or international normalized ratio < 1.7.
  • Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion criteria

  • Cholangiocellular carcinoma (ICC).
  • Patients without image information should be excluded;
  • The survival or patients less than 3 months.
  • Serious medical comorbidities.
  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy.
  • Known history of HIV.
  • History of organ allograft.
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Treatment and study plan

Locoregional therapy

Procedure

TACE procedure The decision to utilize transarterial artery chemoembolization (TACE) was performed through the tumor-feeding artery. The embolization emulsion was a mixture of Epirubicin 30-60 mg, Lobaplatin 30-50 mg, and Lipiodol 10-30 ml, and it was infused into tumor-feeding arteries via a 2.7/2.8 Fr micro-catheter.

HAIC procedure Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.

Other names: TACE/HAIC

Bevacizumab

Drug

15mg/kg or 7.5mg/kg intravenously every 3 weeks

Atezolizumab

Drug

1200mg intravenously every 3 weeks

Tislelizumab

Drug

200mg intravenously every 3 weeks

Toripalimab

Drug

220mg intravenously every 3 weeks

Sintilimab

Drug

200mg intravenously every 3 weeks

Camrelizumab

Drug

200mg intravenously every 3 weeks

Primary outcomes

  1. Progression-Free-Survival (PFS)

    Time frame: 12 months

    Progression was defined as progressive disease by independent radiologic review

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 24 months

    OS is the length of time from the date of inclusion until death from any cause.

  2. Objective response rate (ORR)

    Time frame: 12 months

    ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

  3. Adverse events

    Time frame: 24 months

    Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Duan, MD

CONTACT

[email protected]

13910984586

Qunfang Zhou, MD

CONTACT

[email protected]

86 19868000115

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Efficacy of Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma: a Multicenter, Observational, Real-world Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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