Actively Recruiting
Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
Led by Hunan Cancer Hospital · Updated on 2024-05-09
30
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
CONDITIONS
Official Title
Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before participation
- Histologically or cytologically confirmed hepatocellular carcinoma or cirrhosis meeting American Association for the Study of Liver Diseases clinical diagnostic criteria
- Eligible for China liver cancer staging (CNLC) Stage IIIa and unsuitable for radical treatments such as resection, ablation, or liver transplantation
- Suitable for hepatic arterial infusion chemotherapy (HAIC) without contraindications
- Child-Pugh liver function class A or B
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ and bone marrow function, including specific blood counts, liver enzymes, kidney function, proteinuria, and coagulation parameters
- Negative pregnancy test for sexually active women of childbearing potential; females not of childbearing potential defined as at least 1 year postmenopausal or surgically sterilized
- Use of effective contraception with less than 1% annual failure rate during treatment and for 120 days after the last dose
You will not qualify if you...
- Presence of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma confirmed by histology or cytology
- Recurrence of previous hepatocellular carcinoma
- Autoimmune hepatitis requiring liver biopsy
- History of hepatic encephalopathy or liver transplantation
- Diffuse liver cancer
- Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage
- History of kidney disease or nephrotic syndrome
- Bleeding events from esophageal or gastric varices within past 6 months or severe varicose veins within 3 months
- Arterial or venous thromboembolic events within 6 months, except stable thrombosis after anticoagulation
- Life-threatening bleeding events
- Recent use of aspirin or other platelet inhibitors before first dose
- Uncontrolled hypertension despite treatment, history of hypertensive crisis or encephalopathy
- Symptomatic congestive heart failure (NYHA Class II-IV), uncontrolled arrhythmia, or long QT syndrome
- History of gastrointestinal perforation, fistula, bowel obstruction, extensive bowel resection, or recent inflammatory bowel disease
- Major surgery within 4 weeks or minor surgery within 7 days before first dose, except venipuncture or catheterization
- History or current pulmonary fibrosis or severe lung diseases
- Active hepatitis B or C infection
- Active tuberculosis or recent anti-tuberculosis treatment within 1 year
- HIV or syphilis infection requiring treatment
- Active or uncontrolled serious infections or severe infections within 4 weeks
- Recent use of immunosuppressants, live vaccines, or systemic traditional Chinese medicines with cancer indications
- Prior exposure to agents targeting T cell costimulation or immune checkpoints
- Known allergy to Cadonilimab components
- Participation in other clinical trials within 4 weeks
- Pregnant or breastfeeding females
- Any condition deemed ineligible by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here