Actively Recruiting
A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antiangiogenic Agents
Led by Sun Yat-sen University · Updated on 2023-02-08
100
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a certain period of time, but more than half of the patients are still insensitive to the treatment. There is no evidence-based basis for second-line treatment after the progression of the disease.In view of the effectiveness of Hepatic arterial infusion (HAIC) in the first-line treatment of HCC in the Chinese population, this study intends to launch a prospective intervention study to explore the efficacy and safety of HAIC treatment in patients with advanced HCC after the failure of ICIs and antiangiogenic agents combination therapy, and to provide high-level evidence for optimizing the second-line treatment of advanced HCC in the future.
CONDITIONS
Official Title
A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antiangiogenic Agents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced hepatocellular carcinoma confirmed by biopsy or histology
- Unresectable and/or metastatic liver cancer classified as stage C by Barcelona-Clinic Liver Cancer (BCLC) staging
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Cirrhosis classified as Child-Pugh class A or B without encephalopathy; ascites controlled by diuretics allowed
- Availability of a tumor tissue sample for testing (archival tissue allowed)
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Use of effective barrier birth control during the study and for 4 weeks after treatment completion
- Adequate bone marrow, liver, and kidney function based on lab tests within 7 days before treatment
- Ability and willingness to comply with all study visits, treatment, and lab tests
You will not qualify if you...
- Local liver cancer treatments performed within 4 weeks before the study (surgery, ablation, chemoembolization, or radiotherapy)
- History of liver failure complications such as refractory ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Uncontrolled infections (except hepatitis B and C), heart failure, diabetes, hypertension, unstable angina, arrhythmias, interstitial lung disease, or severe chronic gastrointestinal diseases
- Psychiatric or social conditions limiting ability to give informed consent
- History of active primary immunodeficiency or HIV infection
- Active or past autoimmune or inflammatory diseases such as inflammatory bowel disease, lupus, sarcoidosis, granulomatous vasculitis, rheumatoid arthritis, or uveitis
- Known allergies to study drugs or their components
- Significant gastrointestinal bleeding or bleeding risk within 30 days prior to study entry
- Brain tumors including metastases
- Pregnancy or breastfeeding
- Other malignancies except those treated and disease-free for 5 years, non-melanoma skin cancer, or treated carcinoma in situ without disease
- Use of immunosuppressive drugs within 14 days before treatment except certain steroids and prophylactic uses
- Live attenuated vaccine received within 30 days before treatment
- Uncontrolled high blood pressure (systolic ≥160 mmHg or diastolic ≥100 mmHg) despite medication within 28 days before treatment
- Fertile men or women not willing to use highly effective contraception during and 6 months after treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 500060
Actively Recruiting
Research Team
M
Ming Zhao, M.D. & Ph.D.
CONTACT
N
Ning Lyu, M.D.
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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