Immunotherapy Study — Now Enrolling

When liver cancer
can't be removed —
here's what's possible.

A clinical study is enrolling adults with unresectable hepatocellular carcinoma who haven't had prior systemic therapy. Everyone receives active immunotherapy — nivolumab combined with an investigational antibody. No placebo.

No Placebo Phase I Study First-Line Treatment US Sites Available
Check Your Eligibility Takes under 2 minutes — no medical records needed to start

Study At A Glance

  • No Placebo
    All participants receive active immunotherapy — both arms, every patient
  • Phase I
    Evaluating an ipilimumab biosimilar combined with nivolumab (OPDIVO®)
  • ~12 Weeks
    Initial combination treatment phase (four 3-week cycles)
  • 246 Patients
    Enrolling at sites globally, including US locations
  • Age 18–70
    Adults up to age 70 with unresectable HCC, no prior systemic therapy

Why Participate

What joining this study means for you

When standard surgical options aren't available, the next step matters. This study offers access to a combination immunotherapy — including nivolumab (OPDIVO®), an established treatment for liver cancer — with every participant receiving active treatment and no placebo arm.

Everyone receives active treatment. No exceptions.

This study compares two active immunotherapy regimens — not a drug against a placebo. Whether you're assigned to the HLX13 arm or the reference drug arm, you receive the same combination: an anti-CTLA-4 antibody plus nivolumab (OPDIVO®). No participant receives an inactive treatment.

This is also a double-blind study — meaning neither you nor the clinical team at your site will know which antibody you are receiving during the treatment phase. This is standard practice in biosimilar studies to ensure the results are unbiased.

Close clinical monitoring

Regular assessments by specialist research teams, including imaging every 6 weeks during treatment to track your response. Any changes to your health are reviewed and managed by the study team.

Access to a known combination

Both study arms use nivolumab (OPDIVO®) — an established immunotherapy for unresectable HCC — combined with an anti-CTLA-4 antibody. HLX13 is an investigational biosimilar of that antibody currently under regulatory evaluation. All participants receive this active combination.

Potential to continue treatment

Participants who benefit from the combination phase may continue with nivolumab (OPDIVO®) monotherapy for up to two years after joining — under continued study team supervision.

Advancing liver cancer research

Your participation helps establish whether biosimilar immunotherapy can make the same treatments more broadly accessible. This research benefits future patients with liver cancer worldwide.

What to Expect

How the study works, step by step

After you express interest, a member of the research team will walk you through every stage — including all risks and what each visit involves — before you make any decision.

Step 1

Eligibility Check

Answer a few questions to see if you may qualify — no medical records needed to start.

Under 2 minutes
Step 2

Screening Visit

A study coordinator reviews your medical history and confirms eligibility. You have time to ask questions and decide.

28-day window
Step 3

Combination Treatment

IV infusions of both immunotherapy agents every 3 weeks. Four cycles total, each 3 weeks apart.

~12 Weeks
Step 4

Monitoring & Maintenance

Ongoing imaging and safety visits. If you're benefiting, continued nivolumab monotherapy may follow.

Up to 2 years

Who Can Participate

Am I eligible for this study?

The following gives you a general picture of who this study is designed for. The study team makes the final eligibility determination during screening — these are meant to help you self-assess before reaching out.

You may qualify if you…

  • Are between 18 and 70 years old
  • Have been diagnosed with hepatocellular carcinoma (HCC) that cannot be surgically removed, or whose cancer has progressed after local treatments (such as TACE, ablation, or radiotherapy)
  • Have not had prior whole-body (systemic) therapy — such as immunotherapy, targeted therapy, or chemotherapy — for advanced liver cancer
  • Are fully active in daily life without any physical restrictions (this is a strict requirement — the study requires what's called ECOG Performance Status 0, meaning you can carry out all normal activities without limitation)
  • Have well-compensated liver function (Child-Pugh Class A)
  • Have hepatitis B that is being treated and well-controlled, or hepatitis C (with willingness to receive antiviral therapy)
  • Weigh between 50 kg (110 lbs) and 85 kg (187 lbs)

You likely cannot join if you…

  • Are older than 70
  • Have already received systemic treatment (such as sorafenib, immunotherapy, or chemotherapy) for advanced liver cancer
  • Have previously received any checkpoint inhibitor therapy (such as ipilimumab, pembrolizumab, nivolumab, atezolizumab, or similar drugs)
  • Have active autoimmune disease that requires ongoing steroid or immunosuppressive treatment
  • Have had a liver transplant or organ transplant
  • Have significant fluid buildup in the abdomen (ascites that is causing symptoms or requires treatment)
  • Have known HIV infection
  • Have known lung scarring, pulmonary fibrosis, or interstitial lung disease
  • Have an active serious infection or unexplained fever in the past two weeks
  • Are pregnant, breastfeeding, or unwilling to use contraception during and for several months after the study

Not sure if you qualify? Prior locoregional treatments like TACE, ablation, or radiotherapy do not disqualify you — only prior systemic (whole-body) drug therapy does. If you have hepatitis B and it is being treated, you may still be eligible. The screening team reviews every situation individually. Checking your eligibility is free and does not commit you to anything.

Check Your Eligibility

Takes under 2 minutes · No medical records needed to start · Voluntary at every step

About This Study

Rigorous science. Patient-centered process.

246
Patients enrolling globally
2
Active immunotherapy arms — no placebo
3+
Regulatory agencies overseeing the study (FDA, EMA, NMPA)
Up to 2 yrs
Potential treatment continuation for participants who benefit

Ethically reviewed

This study was reviewed and approved by an independent ethics board (IRB/IEC) before any participant could be enrolled. Oversight continues throughout the study period.

Fully informed consent

Before you make any decision, you will receive written materials about the study, have time to review them, and speak with the study team about any questions or concerns you have.

Specialist research teams

The study is conducted at oncology research centers experienced in immunotherapy clinical trials, with dedicated coordinators supporting participants throughout every phase.

Your choice, always

Participation is completely voluntary. You can withdraw at any time without affecting your access to other medical care. There is no pressure and no penalty for choosing not to join.

Your Questions Answered

Frequently asked questions

Will I receive a placebo?

No. This study does not include a placebo. Every participant receives active immunotherapy — either the investigational antibody (HLX13) or the reference drug ipilimumab (YERVOY®), both in combination with nivolumab (OPDIVO®). No participant receives an inactive treatment.

Can I join if I've already had TACE, ablation, or other local liver treatments?

Yes, in most cases. If your liver cancer has progressed after locoregional treatments such as TACE (transarterial chemoembolization), radiofrequency ablation, or radiation, you may still be eligible — as long as you have not received prior systemic (whole-body) drug therapy for advanced liver cancer.

Systemic therapy means treatments like sorafenib, immunotherapy, or chemotherapy given through the bloodstream. Local treatments applied directly to the liver do not disqualify you.

Can I join if I have hepatitis B?

Potentially yes. Hepatitis B is a very common underlying cause of liver cancer, and the study is designed to include patients with HBV. You may be eligible if your hepatitis B viral levels are adequately controlled and you are on anti-viral treatment before and during the study. The study team will assess your specific HBV situation during screening. Patients with hepatitis C may also be eligible, with willingness to receive standard antiviral therapy.

What is the age limit for this study?

The study enrolls adults aged 18 to 70 years old. If you are older than 70, you are not eligible for this study. If you are between 18 and 70, age is not a barrier to participating — the study team will assess the other eligibility criteria during screening.

Do I need a biopsy to join?

A tissue-confirmed diagnosis of hepatocellular carcinoma is required before you can be fully enrolled. If you already have a biopsy result confirming HCC, no additional biopsy is needed for this purpose. If your HCC diagnosis was made by imaging alone (without tissue confirmation), a biopsy will be required before you are randomized into the study. The study team will discuss exactly what this means for your situation.

What does "no prior systemic therapy" mean exactly?

It means you have not received a whole-body drug treatment — such as immunotherapy, targeted therapy, or chemotherapy — specifically for advanced or metastatic liver cancer.

If you received drug treatment before or after surgery (neoadjuvant or adjuvant therapy) and your cancer did not return for at least 12 months after finishing that treatment, you may still qualify. Local treatments like TACE, ablation, or liver-directed radiation are not systemic therapy and do not disqualify you.

How long does the study last?

The initial combination treatment phase lasts approximately 12 weeks — four treatment cycles, each 3 weeks apart. After that, participants who continue to benefit may receive nivolumab (OPDIVO®) monotherapy for up to two years from the time they joined. There is also a 90-day safety monitoring period after your last infusion of the study drug.

Is participation voluntary? What happens if I want to stop?

Yes, completely. You can choose not to participate or withdraw from the study at any time, for any reason, with no consequences to your other medical care. Before joining, you will receive written information about the study and have time to ask questions and decide — the study team will never pressure you. If you decide to leave the study, the team will ensure you continue to receive appropriate care.

What are the risks of participating?

Immunotherapy combinations like nivolumab and ipilimumab can cause immune-related side effects — conditions where the immune system becomes overactive and affects normal organs. These can include inflammation of the lungs, liver, intestines, or hormone glands, and can range from mild to serious.

Before you decide to join, a member of the study team will explain all known and potential risks in detail and answer every question you have. You will receive written information you can review at home before signing anything. The research team monitors participants throughout the study for any safety concerns.

Ready to find out
if you qualify?

A short eligibility check — no medical records, no commitment — will tell you whether this study may be an option. If you qualify, a study coordinator will reach out to answer any questions and explain the next steps.

Start My Eligibility Check

Takes under 2 minutes · No obligation · Participation is always voluntary