Actively Recruiting
Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)
Led by Koo Foundation Sun Yat-Sen Cancer Center · Updated on 2025-03-06
43
Participants Needed
4
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intra-arterial (IA) therapy is generally used to treat HCC tumors that are too extensive to excise or treat with potentially curative local therapy. IA therapy takes advantage of the fact that the blood supply of HCC comes predominantly from the hepatic artery compared with the surrounding normal liver which is predominantly supplied by portal venous blood. The intent is to deprive the HCC of its blood supply, leading to the death of the tumor. Traditionally, various methods have been used to block the HCC blood supply, but improvements are needed. This study will investigate a new agent designed in the laboratory to block only tumor blood vessels, not blood vessels in the normal liver.
CONDITIONS
Official Title
Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of hepatocellular carcinoma (HCC) confirmed by biopsy or imaging showing characteristic liver lesions
- Barcelona Clinic Liver Cancer (BCLC) Intermediate Stage B or limited Advanced Stage C
- Inadequate response or progression after prior liver-directed or systemic therapies
- Not eligible for curative surgery, liver transplant, or ablation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate liver and kidney function with specified lab value limits
- Pulmonary oxygen saturation above 90% on room air
- Child-Pugh class A to B7 without significant ascites
- Signed informed consent
- Surgically sterile, post-menopausal for at least 2 years if female, or willing to use effective contraception until 2 months after treatment
You will not qualify if you...
- Eligible for liver transplantation or potentially eligible if successfully down-staged
- Prior organ transplantation
- Recent treatment with small molecule drugs, biological agents, investigational therapies, or Y90 within specified time frames
- Other cancers not disease-free for at least 2 years except certain low-risk cancers
- Severe lung disease requiring oxygen or significant pleural effusions
- Serious heart conditions including recent myocardial infarction, unstable arrhythmia, or need for chronic anticoagulation
- Risks related to prolonged QT interval or medications that prolong QT
- Major surgery, vascular injury, or serious illness within 60 days
- Known blood clotting disorders or history of unprovoked thrombosis
- Active infections requiring systemic treatment or uncontrolled viral hepatitis
- Breastfeeding females
- Allergy to iodinated contrast medium not controlled by medication
- Anticoagulation therapy that cannot be safely stopped and restarted around treatment
- Any other condition that poses unacceptable risk or interferes with study participation
- Unwillingness or inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
National Cheng Kung University Hospital (NCKUH)
Tainan, North Dist., Taiwan, 70403
Actively Recruiting
2
Koo Foundation Sun Yat-Sen Cancer Center (KFSYSCC)
Taipei, Pei-Tou Dist., Taiwan, 11259
Actively Recruiting
3
National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng Dist., Taiwan, 100225
Actively Recruiting
4
KFSYSCC
Taipei, Taiwan, 112
Actively Recruiting
Research Team
G
Gabriela Sanchez
CONTACT
J
Jennifer Schulz
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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