bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC

Zhou Qunfang (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. Camrelizumab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and tolerable in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Camrelizumab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Study Design

Study Type:
Anticipated Enrollment :
40 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: bTAE-HAIC combined with Lenvatinib and Camrelizumab

bTAE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks.

Procedure: bTAE-HAIC
bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). 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.

Drug: Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
Other Names:
  • TKI inhibits
  • Drug: Camrelizumab
    200mg intravenously every 2 weeks
    Other Names:
  • programmed cell death protein-1 (PD-1) antibody
  • Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [6 months]

      ORR, as determined based on tumor response according to RECIST 1.1, is defined as

    Secondary Outcome Measures

    1. Progression free survival (PFS) [6 months]

      PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.

    Other Outcome Measures

    1. Overall survival (OS) [12 months]

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

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    1. Clinical diagnosis of HCC.

    2. Age between 18 and 75 years;

    3. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;

    4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).

    5. Child-Pugh class A or B;

    6. Eastern Cooperative Group performance status (ECOG) score of 0-2;

    7. 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

    8. Prothrombin time ≤18s or international normalized ratio < 1.7.

    9. Ability to understand the protocol and to agree to and sign a written informed consent document.

    Exclusion Criteria:
    1. Diffuse HCC;

    2. Extrahepatic metastasis >5;

    3. Obstructive PVTT involving the main portal vein.

    4. Serious medical comorbidities.

    5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

    6. Known history of HIV

    7. History of organ allograft

    8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.

    9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

    10. Evidence of bleeding diathesis.

    11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

    Contacts and Locations


    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guanzhou Guangdong China 510000

    Sponsors and Collaborators

    • Zhou Qunfang


    • Study Director: Zhimei Hunag, MD, Sun Yat-sen University
    • Study Director: Jinhua Huang, Profession, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Zhou Qunfang, Sun Yat-sen University, Sun Yat-sen University Identifier:
    Other Study ID Numbers:
    • Liver Project 3
    First Posted:
    Sep 29, 2023
    Last Update Posted:
    Sep 29, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 29, 2023