Actively Recruiting
Randomized Phase I Study Comparing Ipilimumab Biosimilar HLX13 and US-Sourced YERVOY® As First-Line Treatment for Unresectable Hepatocellular Carcinoma
Led by Shanghai Henlius Biotech · Updated on 2026-03-16
246
Participants Needed
51
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic profile, safety, efficacy, and immunogenicity of HLX13, an ipilimumab biosimilar, compared to the US-sourced YERVOY® in adults with unresectable hepatocellular carcinoma (HCC) who have not previously received systemic therapy. This phase I, multicenter, randomized, double-blind study aims to understand how these treatments behave in the body and their effects on this advanced liver cancer. Participants will be randomly assigned to receive either HLX13 or US-sourced YERVOY® at a dose of 3 mg/kg on the first day of each 3-week cycle, for up to four cycles. Additionally, all subjects will receive EU-sourced OPDIVO® (nivolumab) at 1 mg/kg on the first day of each 3-week cycle for four cycles. Those who benefit from OPDIVO® treatment may continue with local-sourced OPDIVO® every 4 weeks for up to two years after randomization. During the study, participants will undergo blood tests to measure drug concentrations and immune response at multiple points up to 20 weeks after the first dose. Safety will be closely monitored through physical exams, vital signs, laboratory tests, and heart monitoring for up to 13 weeks after dosing. Researchers will also assess tumor response and record any adverse events during treatment and a 90-day safety follow-up period. Overall, participants may be involved in the study for several months, with continued treatment and monitoring as appropriate.
CONDITIONS
Brief 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.
- Male or female aged 18 to 65 years.
- Body weight between 50 kg and 85 kg.
- Histologically confirmed advanced hepatocellular carcinoma not suitable for surgery or locoregional therapies, or progressive disease after such therapies.
- At least one measurable lesion not previously treated, assessed within 4 weeks prior to first dose.
- No prior systemic therapy for relapsed metastatic or advanced hepatocellular carcinoma (prior neo-adjuvant or adjuvant systemic therapy allowed if recurrence after at least 12 months).
- ECOG performance status of 0 within 7 days prior to first dose.
- Child-Pugh Class A cirrhosis within 7 days prior to first dose.
- Left ventricular ejection fraction of 50% or higher.
- Normal major organ functions before first dose.
- For active hepatitis B patients, viral load below specified limits and ongoing anti-HBV treatment.
- Women of childbearing potential must have negative pregnancy tests at screening and before first dose.
You will not qualify if you...
- Other histopathological types of hepatocellular carcinoma (e.g., fibrolamellar, sarcomatoid, mixed cholangiocarcinoma).
- Active malignancies within 3 years except certain localized cured tumors.
- Prior liver, organ, or bone marrow transplantation.
- History of hepatic encephalopathy or clinically significant ascites.
- Tumor thrombus in main portal vein or inferior vena cava, bile duct invasion, or liver occupation over 50%.
- Nervous system disorders at screening.
- Recent bleeding varices or other severe bleeding events.
- Non-healing wounds, fractures, or ulcers at bleeding risk.
- Recent major surgery or trauma.
- Active autoimmune diseases requiring systemic immunosuppression.
- Recent systemic corticosteroid or immunosuppressive treatment above specified doses.
- Active co-infections with hepatitis B and C or hepatitis D.
- HIV infection.
- Active infections needing systemic treatment.
- Uncontrolled cardiovascular diseases.
- Severe lung diseases affecting diagnosis or management.
- Recent use of traditional Chinese herbs with anti-tumor effects.
- Recent treatment with live vaccines.
- Prior immune checkpoint or T-cell costimulatory therapies.
- Recent radical radiotherapy.
- Use of strong CYP3A4 inducers, certain anticoagulants, or high-dose antiplatelet therapy.
- Serious uncontrolled medical disorders increasing risk or interfering with study.
- Anaphylaxis to study drugs or components.
- History of substance abuse.
- Pregnant or lactating women or those planning pregnancy during or shortly after study.
- Participation in another clinical study close to this trial.
- Other conditions deemed unsuitable by investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive treatment with either HLX13, US-sourced YERVOY®, or EU-sourced OPDIVO® on the first day of each 3-week cycle, up to 4 cycles (12 weeks).
4 visits (in-person) every 3 weeks
Duration - Up to 2 years
Participants who benefit from OPDIVO® treatment may continue with OPDIVO® monotherapy every 4 weeks, up to 2 years after randomization, along with safety monitoring after the treatment period ends.
Monthly visits up to 2 years
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
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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