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 (May 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
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–0(Fully active)
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 →
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