Actively Recruiting
Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma
Led by Shanghai Henlius Biotech · Updated on 2026-03-16
246
Participants Needed
51
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, parallel-controlled, phase I clinical study to evaluate the PK characteristics, safety, efficacy, and immunogenicity of HLX13 and US-sourced YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
CONDITIONS
Official Title
Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form approved by an ethics committee
- Male or female aged between 18 and 65 years
- Body weight between 50 and 85 kg
- Histologically confirmed hepatocellular carcinoma (HCC) that is advanced and unresectable
- At least one measurable tumor lesion not previously treated by surgery, radiotherapy, or locoregional therapy
- No prior systemic therapy for metastatic or advanced HCC, except if recurrence occurred 12 months after prior treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 within 7 days before first dose
- Child-Pugh Class A liver cirrhosis within 7 days before first dose
- Left ventricular ejection fraction (LVEF) of at least 50%
- Normal major organ functions before first dose
- For active hepatitis B patients, HBV-DNA less than 500 IU/mL or 2500 copies/mL within 28 days before randomization and ongoing anti-HBV treatment
- For hepatitis C positive patients, agreement to receive standard antiviral therapy
- Women of childbearing potential must have negative pregnancy tests at screening and before first dose
You will not qualify if you...
- Other types of hepatocellular carcinoma such as fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and HCC
- Active malignancies within 3 years before or at screening except for certain cured localized tumors
- History of liver transplant, organ allograft, or bone marrow transplantation
- History of hepatic encephalopathy
- Clinically significant ascites
- Tumor thrombus in main portal vein or inferior vena cava, bile duct invasion, or liver occupation greater than 50%
- Nervous system disorders at screening
- Portal hypertension with recent bleeding esophageal or gastric varices
- Severe bleeding events or non-healing wounds within specified timeframes
- Recent major surgeries or significant injuries
- Active or suspected autoimmune diseases requiring systemic immunosuppressive therapy
- Recent use of systemic corticosteroids or immunosuppressive agents beyond allowed doses
- Active co-infection with both hepatitis B and C or hepatitis D infection
- HIV infection
- Active infections needing systemic treatment within 14 days before screening
- Uncontrolled cardiovascular disease within 6 months before screening
- Severe lung diseases affecting drug safety evaluation
- Recent use of traditional Chinese anti-tumor medicines or live vaccines
- Prior treatment with immune checkpoint inhibitors or strong CYP3A4 inducers
- Use of certain anticoagulants and antiplatelet therapies
- Serious or uncontrolled medical conditions increasing study risk
- Known allergies to study drugs or components
- History of substance abuse
- Pregnant or breastfeeding women or those planning pregnancy during or shortly after the study
- Current participation in another clinical trial or recent exposure to investigational products
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
Oncology Physicians Network (OPN) - Los Alamitos /OPN Healthcare
Glendale, California, United States, 91203
Actively Recruiting
2
Los Angeles Cancer Network
Glendale, California, United States, 91204
Not Yet Recruiting
3
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Not Yet Recruiting
4
D&H National Research Centers, LLC
Margate, Florida, United States, 33063
Actively Recruiting
5
Mid Florida Hematology and oncology Center
Orange City, Florida, United States, 32763
Actively Recruiting
6
Florida Clinical Trials Group
Plantation, Florida, United States, 33322
Not Yet Recruiting
7
Florida Clinical Trials Group
Tamarac, Florida, United States, 33321
Not Yet Recruiting
8
HCA Research Institute, LLC
Brentwood, Tennessee, United States, 37027
Not Yet Recruiting
9
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
10
American Oncology Network Vista Oncology Division/Physician Partner Associate
Olympia, Washington, United States, 98506
Actively Recruiting
11
Northwest Medical Specialties PLLC (NWMS)
Tacoma, Washington, United States, 98405
Actively Recruiting
12
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
13
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
14
Peking university international hospital
Beijing, China
Actively Recruiting
15
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
Actively Recruiting
16
JiLin Cancer Hospital
Changchun, China
Actively Recruiting
17
The First Hospital of Jilin University
Changchun, China
Actively Recruiting
18
People's Hospital of Hunan Province
Changsha, China
Actively Recruiting
19
Chengdu Fifth People's Hospital
Chengdu, China
Actively Recruiting
20
Sichuan Cancer Hospital
Chengdu, China
Actively Recruiting
21
Dongguan People's Hospital
Dongguan, China
Actively Recruiting
22
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
23
Ganzhou People's Hospital
Ganzhou, China
Actively Recruiting
24
Nanfang Hospital, Southern Medical University
Guangzhou, China
Actively Recruiting
25
Hainan General Hospital
Haikou, China
Actively Recruiting
26
Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
27
Harbin Medical University Cancer Hospital
Harbin, China
Actively Recruiting
28
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, China
Actively Recruiting
29
Jinan Central Hospital
Jinan, China
Actively Recruiting
30
Affiliated Hospital of Jining Medical University
Jining, China
Actively Recruiting
31
Linyi Cancer Hospital
Linyi, China
Actively Recruiting
32
Lishui Central Hospital
Lishui, China
Actively Recruiting
33
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Actively Recruiting
34
Jiangxi Cancer Hospital
Nanchang, China
Actively Recruiting
35
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
36
Jiangsu Province Hospital
Nanjing, China
Actively Recruiting
37
The Affiliated Hospital of Nanjing university Medical School
Nanjing, China
Actively Recruiting
38
Guangxi Medical University Cancer Hospital
Nanning, China
Actively Recruiting
39
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
40
Shanghai Gobroad Cancer Hospital
Shanghai, China
Actively Recruiting
41
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
42
Liaoning Cancer Hospital & Institute
Shenyang, China
Actively Recruiting
43
Shengjing Hospital of China Medical University
Shenyang, China
Actively Recruiting
44
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
45
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
46
Hubei Cancer Hospital
Wuhan, China
Actively Recruiting
47
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China
Actively Recruiting
48
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
49
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, China
Actively Recruiting
50
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
51
The first affiliated hospital of zhengzhou university
Zhengzhou, China
Actively Recruiting
Research Team
H
Henlius
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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