🏛️ Verified NIH Record • Updated 2026-03-12

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 (NCT07176650)

A Randomized, Multicenter, Double-Blind, Parallel-Controlled, 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

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Shanghai Henlius Biotech

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Oncology Physicians Network (OPN) - Los Alamitos /OPN Healthcare — Glendale, California

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (51 Sites)

Showing the first 25 of 51 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
  • Florida Clinical Trials Group — Plantation, Florida
  • Florida Clinical Trials Group — Tamarac, Florida
  • HCA Research Institute, LLC — Brentwood, Tennessee
  • Oncology Consultants — Houston, Texas
  • American Oncology Network Vista Oncology Division/Physician Partner Associate — Olympia, Washington
  • Northwest Medical Specialties PLLC (NWMS) — Tacoma, Washington
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing,
  • Peking Union Medical College Hospital — Beijing,
  • Peking university international hospital — Beijing,
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu,
  • JiLin Cancer Hospital — Changchun,
  • The First Hospital of Jilin University — Changchun,
  • People's Hospital of Hunan Province — Changsha,
  • Chengdu Fifth People's Hospital — Chengdu,
  • Sichuan Cancer Hospital — Chengdu,
  • Dongguan People's Hospital — Dongguan,
  • Fujian Cancer Hospital — Fuzhou,
  • Ganzhou People's Hospital — Ganzhou,
  • Nanfang Hospital, Southern Medical University — Guangzhou,
  • Hainan General Hospital — Haikou,

📞 Contact the Study Coordinator

Phone: +86-021-33395800

Email: Xuhui_Hu@henlius.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗