Ipilimumab Biosimilar for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, HLX13 (an ipilimumab biosimilar), for individuals with liver cancer that cannot be surgically removed. The researchers aim to assess the safety and effectiveness of HLX13 compared to an existing treatment, YERVOY®. Participants should have liver cancer that is untreated by medication and too advanced for surgery. This trial offers a chance to explore new options and contribute to advances in cancer treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that patients taking HLX13, a version of the drug ipilimumab, experienced safety results similar to those taking YERVOY®, the original drug. This finding suggests that HLX13 might be well-tolerated. Other research has shown no unexpected side effects, though some patients experienced common ones like tiredness and skin rash, typical for such treatments. As this is a Phase 1 trial, the primary goal is to assess the safety of HLX13 in people. Researchers are closely monitoring for any possible side effects. For those considering participation, it's helpful to know that similar drugs have been approved for other uses, indicating a certain level of safety.12345
Why do researchers think this study treatment might be promising for liver cancer?
Unlike the standard treatments for liver cancer, such as surgery, radiation, and chemotherapy, HLX13 is a biosimilar to Ipilimumab, which is an immune checkpoint inhibitor. Most treatments work by directly attacking cancer cells, but HLX13 works differently by boosting the body's immune system to better recognize and fight cancer cells. Researchers are excited about HLX13 because it could offer a similar therapeutic effect to the original Ipilimumab (YERVOY®) but potentially at a lower cost, making it more accessible to patients. This could be a game-changer in liver cancer treatment by expanding access to effective immunotherapy options.
What evidence suggests that this trial's treatments could be effective for liver cancer?
Research has shown that combination therapies using ipilimumab, such as HLX13, hold promise for treating liver cancer. In this trial, participants will receive either HLX13 or US-sourced YERVOY®. Studies on similar treatments found that patients with liver cancer that cannot be surgically removed lived for a median of 23.7 months. Patients receiving ipilimumab combinations also lived longer compared to those on other treatments like lenvatinib or sorafenib. Additionally, about 30% of patients experienced a significant reduction or disappearance of their cancer. These findings suggest that treatments like HLX13 could offer important benefits for people with advanced liver cancer.12567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either HLX13 or US-sourced YERVOY® as a first-line treatment for unresectable hepatocellular carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HLX13
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai Henlius Biotech
Lead Sponsor
Dr. Jason Zhu
Shanghai Henlius Biotech
Chief Executive Officer since 2023
MBA from Yale University
Dr. Jun Zhu
Shanghai Henlius Biotech
Chief Medical Officer
MD from an unspecified institution
Citations
NCT07176650 | Phase I Clinical Study To Evaluate ...
Patients will receive HLX13 (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles. ... Patients will receive EU-sourced OPDIVO® (EU-sourced ...
NCT06841185 | A Study to Compare the Efficacy, Safety ...
This is a multicenter, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the efficacy, safety, PK, ...
Therapeutic advances in hepatocellular carcinoma - PMC - NIH
The combination demonstrated promising survival outcomes, with a median PFS of 8.78 months and a manageable safety profile, indicating its ...
4.
onclive.com
onclive.com/view/frontline-nivolumab-ipilimumab-delivers-long-term-efficacy-in-unresectable-hccFrontline Nivolumab/Ipilimumab Delivers Long-Term ...
Nivolumab and ipilimumab showed superior overall survival compared to lenvatinib or sorafenib in unresectable HCC, with a median OS of 23.7 ...
5.
dovepress.com
dovepress.com/efficacy-and-safety-of-ipilimumab-plus-anti-pd-1pd-l1-antibodies-combi-peer-reviewed-fulltext-article-JHCEfficacy and Safety of Ipilimumab Plus Anti-PD-1/PD-L1 ...
The present study demonstrates that ipilimumab combination therapy may offer a survival benefit in patients with advanced HCC who have ...
6.
trial.medpath.com
trial.medpath.com/clinical-trial/cdca5fd5eb1cb8d4/nct06841185-ipilimumab-biosimilar-hlx13-hepatocellular-carcinomaA Study to Compare the Efficacy, Safety, Immunogenicity, and ...
A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with ...
Future perspectives on immunotherapy for hepatocellular ...
Outcomes of liver transplantation under the Milan criteria are excellent, with an 85%–90% disease-free survival and 70%–80% OS at 5 years.
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