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NCT Number: NCT06609863

dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma

This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

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Key information

Conditions

Advanced Hepatocellular Carcinoma Adenocarcinoma Atezolizumab Bevacizumab Carcinoma Carcinoma, Hepatocellular Chemotherapy Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Drug-eluting transcatheter arterial embolization (dTACE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The anti-VEGF combined programmed cell death protein-1 legend 1 (PD-L1) inhibitor were effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy (dTACE/HAIC) combined with Bevacizumab and Atezolizumab inhibitor in patients with huge hepatocellular carcinoma who can not receive radical therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of HCC.
  • Age between 18 and 75 years;
  • The maximum tumor size ≥10 cm;
  • Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
  • limited metastases (≤5).
  • Child-Pugh class A or B;
  • Eastern Cooperative Group performance status (ECOG) score of 0-1;
  • 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

  • Diffuse HCC;
  • Extrahepatic metastasis >5;
  • Obstructive PVTT involving mesenteric vena cava (PVTT IV).
  • Serious medical comorbidities.
  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
  • Eastern Cooperative Group performance status (ECOG) score of ≥2;
  • 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

dTACE-HAIC

Procedure

dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres were used (100-300um). The microcatheter was reserved at the proper/left/right hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 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. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. Progression-Free-Survival (PFS)

    Time frame: 12 months

    PFS is the length of time from the date of inclusion until tumor progression.

  2. Overall survival (OS)

    Time frame: 24 months

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

Study contacts

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

Qunfang Zhou, MD

CONTACT

[email protected]

86 19868000115

Ye Liang, MD

CONTACT

[email protected]

8618824105018

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Dec 3, 2024

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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