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

Last updated: September 20, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Cancer

Cancer/tumors

Treatment

Camrelizumab

bTAE-HAIC

Lenvatinib

Clinical Study ID

NCT06061276
Liver Project 3
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 limitedmetastases (≤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 ≤ 1.5or 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 informedconsent document.

Exclusion

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 orhepatic encephalopathy

  6. Known history of HIV

  7. History of organ allograft

  8. Known or suspected allergy to the investigational agents or any agent given inassociation 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 priorto study entry.

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Camrelizumab
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guanzhou, Guangdong 510000
    China

    Active - Recruiting

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