New biosimilar could make liver cancer treatment more accessible

NCT ID NCT07176650

Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called HLX13, which is a biosimilar (a very similar copy) of the approved immunotherapy YERVOY, in people with advanced liver cancer that cannot be removed by surgery. The trial will compare HLX13 to the original YERVOY, both given alongside another immunotherapy (nivolumab). About 246 participants will receive either HLX13 or YERVOY to see if the biosimilar works just as well and has similar safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: HLX13 (a biosimilar of ipilimumab, an immunotherapy drug)
What this could lead to: If HLX13 works as well as YERVOY, it could provide a more affordable treatment option for advanced liver cancer.
What could go wrong: This is an early Phase 1 trial focused on safety and drug levels, not yet on effectiveness. The biosimilar may not match the original drug, and side effects from immunotherapy can be severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 246 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. 2. Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF. 3. Body weight: 50 kg-85 kg. 4. 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. 5. 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. 6. 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. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 within 7 days prior to the first dose. 8. Cirrhotic status of Child-Pugh Class A within 7 days prior to the first dose. 9. Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiography. 10. Normal major organ functions prior to the first dose. 11. 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. 12. Women of childbearing potential should have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the first dose. Exclusion Criteria: 1. With other histopathological types of hepatocellular carcinoma, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma. 2. 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. 3. Liver transplant, or organ allograft or allogeneic bone marrow transplantation prior to screening, or the above transplantation is scheduled during the study. 4. History of hepatic encephalopathy prior to screening. 5. Clinically significant ascites. 6. 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. 7. Presence of nervous system disorders at screening. 8. 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. 9. Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 3 months prior to screening except for esophageal or gastric varices. 10. History of non-healing wounds, bone fractures, or ulcers at risk of bleeding within 3 months prior to randomization. 11. 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. 12. Known active or suspected autoimmune diseases prior to screening. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate. 13. 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. 14. 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. 15. Subjects with a history of co-infection with both hepatitis B and C. 16. Human immunodeficiency virus (HIV) infection prior to screening (or positive anti-HIV at screening). 17. 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. 18. Uncontrolled cardiovascular diseases within 6 months prior to screening. 19. 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. 20. Patients who have used traditional Chinese herbs or medicines with anti-tumor indications within 14 days prior to randomization. 21. 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. 22. 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. 23. Radical radiotherapy within 4 weeks prior to randomization. 24. 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). 25. 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. 26. Anaphylaxis to ipilimumab, nivolumab, or any other monoclonal antibody, or any component of the IMPs prior to screening. 27. History of psychotropic substance abuse or illicit drug use as judged by the investigator prior to screening. 28. Pregnant and lactating women, and those intending to become pregnant during the study or within 5 months after the last study treatment. 29. 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. 30. Patients who have other conditions not suitable for inclusion per investigator's judgments.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma (HCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

51 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital of Jining Medical University
RECRUITING

Jining, China
American Oncology Network Vista Oncology Division/Physician Partner Associate
RECRUITING

Olympia, Washington, 98506, United States
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING

Beijing, China
Cancer Specialists of North Florida
NOT_YET_RECRUITING

Jacksonville, Florida, 32256, United States
Chengdu Fifth People's Hospital
RECRUITING

Chengdu, China
D&H National Research Centers, LLC
RECRUITING

Margate, Florida, 33063, United States
Dongguan People's Hospital
RECRUITING

Dongguan, China
Florida Clinical Trials Group
NOT_YET_RECRUITING

Plantation, Florida, 33322, United States
Florida Clinical Trials Group
NOT_YET_RECRUITING

Tamarac, Florida, 33321, United States
Fudan University Shanghai Cancer Center
RECRUITING

Shanghai, China
Fujian Cancer Hospital
RECRUITING

Fuzhou, China
Ganzhou People's Hospital
RECRUITING

Ganzhou, China
Guangxi Medical University Cancer Hospital
RECRUITING

Nanning, China
HCA Research Institute, LLC
NOT_YET_RECRUITING

Brentwood, Tennessee, 37027, United States
Hainan General Hospital
RECRUITING

Haikou, China
Harbin Medical University Cancer Hospital
RECRUITING

Harbin, China
Henan Cancer Hospital
RECRUITING

Zhengzhou, China
Hubei Cancer Hospital
RECRUITING

Wuhan, China
JiLin Cancer Hospital
RECRUITING

Changchun, China
Jiangsu Province Hospital
RECRUITING

Nanjing, China
Jiangxi Cancer Hospital
RECRUITING

Nanchang, China
Jinan Central Hospital
RECRUITING

Jinan, China
Liaoning Cancer Hospital & Institute
RECRUITING

Shenyang, China
Linyi Cancer Hospital
RECRUITING

Linyi, China
Lishui Central Hospital
RECRUITING

Lishui, China
Los Angeles Cancer Network
NOT_YET_RECRUITING

Glendale, California, 91204, United States
Mid Florida Hematology and oncology Center
RECRUITING

Orange City, Florida, 32763, United States
Nanfang Hospital, Southern Medical University
RECRUITING

Guangzhou, China
Northwest Medical Specialties PLLC (NWMS)
RECRUITING

Tacoma, Washington, 98405, United States
Oncology Consultants
RECRUITING

Houston, Texas, 77030, United States
Oncology Physicians Network (OPN) - Los Alamitos /OPN Healthcare
RECRUITING

Glendale, California, 91203, United States
Peking Union Medical College Hospital
RECRUITING

Beijing, China
Peking university international hospital
RECRUITING

Beijing, China
People's Hospital of Hunan Province
RECRUITING

Changsha, China
Shanghai Gobroad Cancer Hospital
RECRUITING

Shanghai, China
Shengjing Hospital of China Medical University
RECRUITING

Shenyang, China
Sichuan Cancer Hospital
RECRUITING

Chengdu, China
Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine
RECRUITING

Hangzhou, China
The Affiliated Hospital of Nanjing university Medical School
RECRUITING

Nanjing, China
The First Affiliated Hospital of Bengbu Medical University
RECRUITING

Bengbu, China
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING

Luoyang, China
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
RECRUITING

Hefei, China
The First Affiliated Hospital of Xi 'an Jiaotong University
RECRUITING

Xi'an, China
The First Hospital of Jilin University
RECRUITING

Changchun, China
The Fourth Hospital of Hebei Medical University
RECRUITING

Shijiazhuang, China
The Second Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, China
The first affiliated hospital of zhengzhou university
RECRUITING

Zhengzhou, China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING

Tianjin, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
RECRUITING

Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING

Wuhan, China
Zhongshan Hospital, Fudan University
RECRUITING

Shanghai, China

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