Actively Recruiting
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
Eligibility Criteria
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
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
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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
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3
Deng zhou People's Hospital
Nanyang, Henan, China
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4
Nan Yang Central Hospital
Nanyang, Henan, China
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5
General Hospital of Pingmei Shenma Group
Pingdingshan, Henan, China
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6
First People's Hospital of Shangqiu
Shangqiu, Henan, China
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7
Shangqiu Municipal Hospital
Shangqiu, Henan, China
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8
Xin Yang Central Hospital
Xinyang, Henan, China
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9
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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10
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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11
Zhengzhou Central Hospital
Zhengzhou, Henan, China
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12
Zhou Kou Central Hospital
Zhoukou, Henan, China
Actively Recruiting
13
First People's Hospital of Zhu Madian
Zhumadian, Henan, China
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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
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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