Actively Recruiting
HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-02-06
38
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm exploratory clinical study to evaluate the efficacy and safety of HAIC in combination with Sintilimab and Donafenib in patients with BCLC-C stage who have not received prior systemic therapy
CONDITIONS
Official Title
HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- ECOG performance status scores of 0 or 1
- Confirmed diagnosis of hepatocellular carcinoma or cirrhosis meeting AASLD clinical criteria
- Barcelona Clinic Liver Cancer (BCLC) stage C
- Newly diagnosed patients with no prior tumor treatment
- Child Pugh score of 7 or less
- Estimated survival longer than 12 weeks
- At least one tumor lesion measurable by RECIST version 1.1
- Adequate organ and bone marrow function
You will not qualify if you...
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma diagnosis
- History of hepatic encephalopathy or liver transplantation
- Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage
- Active acute or chronic hepatitis B or C infection with high viral loads or positive markers
- Central nervous system metastases
- Recent bleeding from esophageal or gastric varices or high-risk varices
- Life-threatening bleeding events within past 3 months
- Arterial or venous thromboembolic events within past 6 months
- Tumor thrombus involving main portal vein branches or inferior vena cava
- Use of high-dose aspirin or platelet-inhibiting drugs within 2 weeks before first dose
- Uncontrolled hypertension despite treatment or history of hypertensive crisis
- Unresolved toxicity from previous therapies above grade 1
- Symptomatic congestive heart failure or serious arrhythmias
- Serious bleeding disorders or current thrombolytic therapy
- History of gastrointestinal perforation, fistula, obstruction, or inflammatory bowel disease within 6 months
- Use of immunosuppressants within 4 weeks before first dose except local or low-dose glucocorticoids
- Receipt of live attenuated vaccine within 4 weeks before first dose or planned during study
- Major surgery within 4 weeks before first dose or unhealed wounds
- Local liver cancer treatment within 4 weeks before first dose
- Use of systemic traditional Chinese medicines or immunomodulators within 2 weeks before first dose
- Uncontrolled metabolic or non-malignant organ diseases or other conditions increasing medical risk or survival uncertainty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
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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