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Recruiting NCT06061276

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

No phase Interventional Liver Diseases Hepatocellular Carcinoma Immunotherapy Camrelizumab

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bTAE-HAIC, Lenvatinib, Camrelizumab.
Who it may be relevant to
Registry conditions: Liver Diseases, Hepatocellular Carcinoma, Immunotherapy, Camrelizumab. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma

Overview

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.

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.

Interventions

  • 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 regi
  • Drug Lenvatinib
    12 mg (or 8 mg) once daily (QD) oral dosing.
  • Drug Camrelizumab
    200mg intravenously every 2 weeks

Primary outcome measures

  • Objective response rate (ORR) [Time frame: 6 months]
Secondary outcome measures (1)
  • Progression free survival (PFS) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of HCC.
  • Age between 18 and 75 years;
  • The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
  • Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).
  • 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

  • Diffuse HCC;
  • Extrahepatic metastasis >5;
  • Obstructive PVTT involving the main portal vein.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guanzhou

Identifiers

NCT: NCT06061276 · Liver Project 3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗