Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05788835

DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial

Led by Xuhua Duan · Updated on 2023-03-29

220

Participants Needed

16

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC

CONDITIONS

Official Title

DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with unresectable hepatocellular carcinoma (HCC) meeting clinical or pathological diagnostic criteria
  • At least one measurable tumor lesion with diameter 6510mm or lymph node short diameter 6515mm
  • Tumor size: sum diameter of 1 to 3 tumors 655cm, BCLC stage C
  • Age between 18 and 75 years, any gender
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Expected life span of 3 months or more
  • No severe comorbidities like hypertension, coronary heart disease, or mental illness
  • Child-Pugh liver function class A or B
  • Hepatitis B virus DNA less than 2000 IU/ml
  • Women of childbearing age must have a pregnancy test within 7 days before enrollment
  • Signed informed consent and good treatment compliance
Not Eligible

You will not qualify if you...

  • Large liver tumors occupying 60% or more of liver volume or major portal vein thrombus occupying 50% or more of vascular diameter
  • Tumor thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula
  • Prior local treatments such as TACE, radiotherapy, radioactive particle implantation, systemic chemotherapy, targeted drugs, or immunotherapy
  • Diffuse liver cancer
  • Severe heart conditions including grade II or higher myocardial ischemia, myocardial infarction, or poorly controlled arrhythmias
  • History of gastrointestinal bleeding within 6 months or bleeding tendency
  • Abnormal clotting or receiving thrombolytic or anticoagulant therapy
  • Central nervous system or brain metastases
  • HIV infection, pregnancy, lactation, or preparing for liver transplantation (except previous transplantation)
  • Systemic failure with estimated survival less than 3 months
  • Severe kidney dysfunction
  • Inability to complete treatment plan or loss of control within 3 months after enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Luo He Central Hospital

Luohe, Henan, China

Actively Recruiting

2

Luo Yang Central Hospital

Luoyang, Henan, China

Actively Recruiting

3

Deng zhou People's Hospital

Nanyang, Henan, China

Actively Recruiting

4

Nan Yang Central Hospital

Nanyang, Henan, China

Actively Recruiting

5

General Hospital of Pingmei Shenma Group

Pingdingshan, Henan, China

Actively Recruiting

6

First People's Hospital of Shangqiu

Shangqiu, Henan, China

Actively Recruiting

7

Shangqiu Municipal Hospital

Shangqiu, Henan, China

Actively Recruiting

8

Xin Yang Central Hospital

Xinyang, Henan, China

Actively Recruiting

9

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

10

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

11

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Actively Recruiting

12

Zhou Kou Central Hospital

Zhoukou, Henan, China

Actively Recruiting

13

First People's Hospital of Zhu Madian

Zhumadian, Henan, China

Actively Recruiting

14

Zhu Ma Dian Central Hospital

Zhumadian, Henan, China

Actively Recruiting

15

Zhu Madian Traditional Chinese Medicine Hospital

Zhumadian, Henan, China

Actively Recruiting

16

Second People's Hospital of Jiaozuo

Jiaozuo, China

Actively Recruiting

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Research Team

X

Xuhua Duan, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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