Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06061276

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

Led by Sun Yat-sen University · Updated on 2024-09-23

40

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of hepatocellular carcinoma (HCC)
  • Age between 18 and 75 years
  • Maximum tumor size at least 10 cm and total tumor size at least 15 cm
  • Intermediate-advanced huge HCC, advanced HCC with portal vein tumor thrombosis (PVTT) type I or II, or limited metastases (5 or fewer)
  • Child-Pugh liver function class A or B
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Hemoglobin level of at least 8.5 g/dL
  • Total bilirubin level of 30 mmol/L or less
  • Serum albumin level of at least 32 g/L
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels no higher than 5 times the upper limit of normal
  • Serum creatinine no higher than 1.5 times the upper limit of normal
  • International normalized ratio (INR) of 1.5 or less or normal prothrombin time (PT) and activated partial thromboplastin time (APTT)
  • Absolute neutrophil count (ANC) greater than 1,500/mm3
  • Prothrombin time of 18 seconds or less or INR less than 1.7
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Diffuse hepatocellular carcinoma
  • More than 5 extrahepatic metastases
  • Obstructive portal vein tumor thrombosis involving the main portal vein
  • Serious medical comorbidities
  • Evidence of liver failure including ascites, gastrointestinal bleeding, or hepatic encephalopathy
  • Known history of HIV infection
  • History of organ transplant
  • Known or suspected allergy to study drugs or related agents
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic treatment
  • Evidence of bleeding disorders
  • Clinically significant gastrointestinal bleeding within 30 days before study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

Q

Qunfnag Zhou, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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