OncoMatch/Clinical Trials/NCT07176650
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
Is NCT07176650 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including HLX13 and Yervoy for hepatocellular carcinoma (hcc).
Treatment: HLX13 · Yervoy · OPDIVO — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–0(Fully active)
Demographics
Prior therapy
Cannot have received: systemic therapy
Exception: prior neo-adjuvant or adjuvant systemic therapy is permitted if recurrence occurs ≥12 months after treatment completion
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.
Cannot have received: immune checkpoint blockade therapy (CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors)
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.
Cannot have received: radical radiotherapy
Radical radiotherapy within 4 weeks prior to randomization.
Lab requirements
Liver function
Cirrhotic status of Child-Pugh Class A within 7 days prior to the first dose.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiography.
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Oncology Physicians Network (OPN) - Los Alamitos /OPN Healthcare · Glendale, California
- Los Angeles Cancer Network · Glendale, California
- Cancer Specialists of North Florida · Jacksonville, Florida
- D&H National Research Centers, LLC · Margate, Florida
- Mid Florida Hematology and oncology Center · Orange City, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07176650 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages