A Phase 3 interventional study of HLX13 and US-sourced YERVOY® in Hepatocellular Carcinoma (HCC), sponsored by Shanghai Henlius Biotech. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Shanghai Henlius Biotech (part of Fosun Pharma) · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the efficacy, safety, PK, and immunogenicity of HLX13 and YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
This study includes three treatment groups. Patients will be randomly assigned at a 2:1:1 ratio to the HLX13, US-sourced YERVOY®, or EU-sourced YERVOY® group to receive the treatment of IMPs in combination with nivolumab.
Patients with good tolerability and disease control will receive HLX13 or YERVOY® in combination with nivolumab on the first day of every 3 weeks for up to 4 cycles. PK and immunogenicity blood sampling will be conducted during the treatment period. After the four treatment cycles, all subjects will be subsequently treated with nivolumab monotherapy until investigator-assessed disease progression, initiation of a new anti-neoplastic therapy, withdrawal of informed consent, death, unacceptable toxicity, or up to 1 year after randomization, whichever occurs first.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 656 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Shanghai Henlius Biotech is the lead sponsor of 131 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.
Drug: HLX13
US-sourced ipilimumab
Drug: US-sourced YERVOY®
EU-sourced ipilimumab
Drug: EU-sourced YERVOY®
HLX13 (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles
US-sourced YERVOY® (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles
EU-sourced YERVOY® (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles
Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 21
Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Best Objective Response Rate (ORR) up to Week 24 (assessed by Independent Radiology Review Committee [IRRC] based on RECIST v1.1)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 24
Maximum serum drug concentration (Cmax) after the first dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 21
Trough serum drug concentration (Ctrough) after the first dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 21
Time to reach maximum serum drug concentration (Tmax) after the first dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 21
Elimination half-life (t1/2) after the first dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 21
Total clearance (CL) after the first dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 21
Volume of distribution during terminal phase (Vz) after the first dose
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 21
Time to reach maximum serum drug concentration at steady state (Tmax, ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Maximum serum drug concentration at steady state (Cmax, ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Minimum serum drug concentration at steady state (Cmin, ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Elimination half-life (t1/2) at steady state
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Volume of distribution at steady state (Vss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Total clearance at steady state (CLss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Accumulation ratio of AUC (Rac, AUC)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
Accumulation ratio of Cmax (Rac, Cmax)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 85
ORR assessed by IRRC (based on RECIST v1.1)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 30
ORR assessed by investigators (based on RECIST v1.1)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 48
Duration of Response (DOR) assessed by investigators (based on RECIST v1.1)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 48
Time to Response (TTR) assessed by investigators (based on RECIST v1.1)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 48
Progression-Free Survival (PFS) Status assessed by investigators (based on RECIST v1.1)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 48
Progression-Free Survival Rate (PFSR) assessed by investigators (based on RECIST v1.1) at Weeks 24 and 48
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 48
Overall Survival (OS)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to 1 year
Overall Survival Rate (OSR) assessed by investigators (based on RECIST v1.1) at Weeks 24 and 48
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Week 48
Adverse events (AEs)
Time frame: Up to Month 15
Serious adverse events (SAEs)
Time frame: Up to Month 15
Incidence of anti-drug antibodies (ADAs).
Time frame: Up to 1 year
Incidence of neutralizing antibodies (NAbs).
Time frame: Up to 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: HLX13