Actively Recruiting
Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）.
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-04-19
30
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma. All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first.
CONDITIONS
Official Title
Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Age between 18 and 75 years, both males and females eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival of at least 3 months.
- Confirmed hepatocellular carcinoma at BCLC stage B or C based on clinical criteria.
- Not suitable for curative surgery or ablation and no prior systemic anti-tumor therapy for unresectable HCC.
- Liver function classified as Child-Pugh class A.
- Sufficient organ function.
You will not qualify if you...
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma confirmed by histology or cytology.
- Other malignant tumors within 5 years prior to enrollment, except certain cured cancers.
- Poor compliance or inability to cooperate with treatment response assessments.
- History of or current central nervous system metastasis or leptomeningeal metastasis.
- Presence of extrahepatic metastasis.
- History of hepatic encephalopathy or liver transplantation.
- Symptoms or recurrent effusions requiring repeated drainage.
- Current participation in other interventional clinical research or recent use of investigational drugs/devices within 4 weeks.
- History or presence of non-infectious pneumonia or interstitial lung disease requiring corticosteroid treatment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300308
Actively Recruiting
Research Team
H
Huikai Li, MD
CONTACT
Y
Yang Liu, doctor
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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