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Hepatocellular Carcinoma (HCC)Phase 1NCT07176650

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

A Phase 1 study testing HLX13, Yervoy and OPDIVO in people with Hepatocellular Carcinoma (HCC), run by Shanghai Henlius Biotech at 51 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
HLX13, Yervoy and OPDIVO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
51 sitesin 2 countries
Study dates
25 Nov 2025to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.
  • Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF.
  • Body weight: 50 kg-85 kg.
  • Histologically diagnosed hepatocellular carcinoma (HCC); and must have an advanced HCC, defined as: a) not eligible for curative surgical and/or locoregional therapies; or b) progressive disease after surgical and/or locoregional therapies. Subjects with only a radiologic diagnosis of hepatocellular carcinoma may be enrolled for screening in the study but histological confirmation is mandatory prior to randomization.
  • At least one measurable lesion as assessed by investigator based on RECIST v1.1 within 4 weeks prior to the first dose in this study. The measurable lesion is not from sites that have been previously treated with surgery, radiotherapy, and/or locoregional therapy.
  • No systemic therapy for relapsed metastatic or advanced hepatocellular carcinoma prior to screening. Note: prior neo-adjuvant or adjuvant systemic therapy is permitted if recurrence occurs ≥12 months after treatment completion.
Show all 12Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 within 7 days prior to the first dose.
  • Cirrhotic status of Child-Pugh Class A within 7 days prior to the first dose.
  • Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiography.
  • Normal major organ functions prior to the first dose.
  • For patients with active hepatitis B virus (HBV), the HBV-DNA must be less than 500 IU/mL or 2500 copies/mL within 28 days prior to the randomization, an anti-HBV treatment (e.g., entecavir) has been started prior to the randomization, and patients are willing to continue the treatment during this study. Patients with positive HCV-RNA must agree to receive standard anti-viral therapy per the local standard of care.
  • Women of childbearing potential should have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the first dose.

Who cannot join

  • With other histopathological types of hepatocellular carcinoma, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma.
  • Other malignancies active within 3 years prior to or at screening except for localized tumors that have been cured such as basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Liver transplant, or organ allograft or allogeneic bone marrow transplantation prior to screening, or the above transplantation is scheduled during the study.
  • History of hepatic encephalopathy prior to screening.
  • Clinically significant ascites.
  • Patients with tumor thrombus at the main portal vein (Vp4), or inferior vena cava prior to screening, or clear invasion into the bile duct, or HCC with ≥50% liver occupation.
Show all 30Show fewer
  • Presence of nervous system disorders at screening.
  • Evidence of portal hypertension with bleeding esophageal or gastric varices within 6 months prior to the randomization. The aforementioned patients have undergone endoscopy to exclude those with high hemorrhage risk may be enrolled. For a patient receiving endoscopy within 6 months prior to randomization, repeat examination is not required.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 3 months prior to screening except for esophageal or gastric varices.
  • History of non-healing wounds, bone fractures, or ulcers at risk of bleeding within 3 months prior to randomization.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the randomization or those who receive minor surgical procedures (e.g., core biopsy) within 7 days prior to randomization.
  • Known active or suspected autoimmune diseases prior to screening. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate.
  • Treatment with systemic corticosteroids (> equivalent dose of 10 mg/day prednisone) or other immunosuppressive agents within 14 days prior to the first dose or during the study. However, for patients with conditions other than active autoimmune diseases, inhaled or topical steroids or adrenocortical hormone replacement therapy (no more than the equivalent dose of 10 mg/day prednisone) are allowed.
  • Active co-infection with both hepatitis B and C (or detectable HBV surface antigen or HBV-DNA and HCV-RNA at screening), or hepatitis D infection in subjects with hepatitis B.
  • Subjects with a history of co-infection with both hepatitis B and C.
  • Human immunodeficiency virus (HIV) infection prior to screening (or positive anti-HIV at screening).
  • Any active infections (including, but not limited to bacteria, fungi, mycoplasma, chlamydia, and herpes zoster virus) requiring systemic treatment within 14 days prior to screening.
  • Uncontrolled cardiovascular diseases within 6 months prior to screening.
  • Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity prior to screening.
  • Patients who have used traditional Chinese herbs or medicines with anti-tumor indications within 14 days prior to randomization.
  • Patients who have received treatment with live vaccines within 28 days prior to randomization. Those who received inactivated viral vaccines for seasonal influenza or COVID-19 are eligible.
  • Patients who have received any T-cell costimulatory agents or immune checkpoint blockade therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.
  • Radical radiotherapy within 4 weeks prior to randomization.
  • Other prior/concomitant therapy: a) Treatment with strong CYP3A4 inducers within 1 week prior to randomization, including rifampin (and its analogues) or St. John's wort. b) Use of anticoagulants such as, warfarin or similar agents requiring therapeutic INR monitoring. Note: Treatment with low molecular weight heparin is allowed. c) Treatment with anti platelet therapy (aspirin at dose ≥ 300 mg/day, clopidogrel at dose ≥75 mg/day).
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or IMP administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Anaphylaxis to ipilimumab, nivolumab, or any other monoclonal antibody, or any component of the IMPs prior to screening.
  • History of psychotropic substance abuse or illicit drug use as judged by the investigator prior to screening.
  • Pregnant and lactating women, and those intending to become pregnant during the study or within 5 months after the last study treatment.
  • Currently participating in another clinical study prior to screening, or less than 4 weeks or 5 half-lives of the IMPs in the previous study, whichever is longer, between the screening of the study and the end of treatment in the previous study.
  • Patients who have other conditions not suitable for inclusion per investigator's judgments.

Trial locations and contacts

51 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Henlius contact

+86-021-33395800

Xuhui_Hu@henlius.com

51 sites in 2 countries

China40 sites, 40 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Recruiting

  • Peking Union Medical College Hospital

    Beijing

    Recruiting

  • Peking university international hospital

    Beijing

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

    Recruiting

  • JiLin Cancer Hospital

    Changchun

    Recruiting

  • The First Hospital of Jilin University

    Changchun

    Recruiting

  • People's Hospital of Hunan Province

    Changsha

    Recruiting

  • Chengdu Fifth People's Hospital

    Chengdu

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu

    Recruiting

  • Dongguan People's Hospital

    Dongguan

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

  • Ganzhou People's Hospital

    Ganzhou

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou

    Recruiting

  • Hainan General Hospital

    Haikou

    Recruiting

  • Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine

    Hangzhou

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin

    Recruiting

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei

    Recruiting

  • Jinan Central Hospital

    Jinan

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining

    Recruiting

  • Linyi Cancer Hospital

    Linyi

    Recruiting

  • Lishui Central Hospital

    Lishui

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    Recruiting

  • The Affiliated Hospital of Nanjing university Medical School

    Nanjing

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Recruiting

  • Shanghai Gobroad Cancer Hospital

    Shanghai

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

  • Hubei Cancer Hospital

    Wuhan

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Recruiting

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

  • The first affiliated hospital of zhengzhou university

    Zhengzhou

    Recruiting

Other trials in China

United States11 sites, 11 recruiting

  • HCA Research Institute, LLC

    Brentwood, Tennessee, 37027

    Not yet recruiting

  • Oncology Physicians Network (OPN) - Los Alamitos /OPN Healthcare

    Glendale, California, 91203

    Recruiting

  • Los Angeles Cancer Network

    Glendale, California, 91204

    Not yet recruiting

  • Oncology Consultants

    Houston, Texas, 77030

    Recruiting

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

    Not yet recruiting

  • D&H National Research Centers, LLC

    Margate, Florida, 33063

    Recruiting

  • American Oncology Network Vista Oncology Division/Physician Partner Associate

    Olympia, Washington, 98506

    Recruiting

  • Mid Florida Hematology and oncology Center

    Orange City, Florida, 32763

    Recruiting

  • Florida Clinical Trials Group

    Plantation, Florida, 33322

    Not yet recruiting

  • Northwest Medical Specialties PLLC (NWMS)

    Tacoma, Washington, 98405

    Recruiting

  • Florida Clinical Trials Group

    Tamarac, Florida, 33321

    Not yet recruiting

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Blind, Parallel-Controlled, 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

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.

Being tested
HLX13, Yervoy, OPDIVO
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX13Drug

    Patients will receive HLX13 (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.

  • YervoyDrug

    Patients will receive US-sourced YERVOY® (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.

  • OPDIVODrug

    Patients will receive EU-sourced OPDIVO® (EU-sourced nivolumab) (1 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles. Subjects who may continue to benefit from OPDIVO® treatment as assessed by investigators will be subsequently treated with local-sourced OPDIVO® monotherapy every 4 weeks, up to 2 year after randomization.

Study groups in NCT07176650
Study groupRoleWhat they receive
HLX13 GroupExperimentalNot described
Receives: Drug: HLX13; Drug: OPDIVO
US-sourced YERVOY® GroupActive comparatorNot described
Receives: Drug: Yervoy; Drug: OPDIVO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 21 days after the 1st dose (3 weeks)

  2. Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 4th dose

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

Secondary outcomes (17)

  1. Maximum serum drug concentration (Cmax)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

  2. Maximum serum drug concentration at steady-state (Cmax,ss)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

  3. Trough serum drug concentration (Ctrough)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

  4. Trough serum drug concentration at steady-state (Ctrough,ss)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

  5. Time to reach maximum serum drug concentration (Tmax)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

  6. Time to reach maximum serum drug concentration at steady-state (Tmax,ss)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

  7. Adverse events (AEs)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 90-day safety follow-up (21 weeks)

  8. Serious adverse events (SAEs)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 90-day safety follow-up (21 weeks)

  9. Adverse events of special interest (AESIs)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 90-day safety follow-up (21 weeks)

  10. Number of participants with abnormal vital signs

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (13 weeks)

  11. Number of participants with abnormal physical examination findings

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (13 weeks)

  12. Number of participants with abnormal Laboratory tests results (hematology, serum chemistry, endocrine function, coagulation function, and myocardial enzymes)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (13 weeks)

  13. Number of participants with abnormal 12-lead ECG readings

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (13 weeks)

  14. Objective response rate (ORR)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of treatment (12 weeks)

  15. Time to response (TTR)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of treatment (12 weeks)

  16. Incidence of anti-drug antibody (ADA)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

  17. Incidence of neutralizing antibody (NAb)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from time 0 to 78 days after the 4th dose (20 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start25 Nov 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176650
Sponsor's protocol ID
HLX13-HCC102
Status last verified
Mar 2026
First submitted
1 Sep 2025
Last updated
16 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX13, Yervoy and OPDIVO in people with Hepatocellular Carcinoma (HCC), run by Shanghai Henlius Biotech at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Henlius (+86-021-33395800, Xuhui_Hu@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose (time frame: from time 0 to 21 days after the 1st dose (3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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