A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma (NCT04194775)
A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of Nofazinlimab (CS1003) in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)
🩺 Plain-English Summary (8th-Grade Level)
This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product and lenvatinib is selected as the basic treatment for HCC.
Who can join: Review the eligibility criteria below.
Location: Southern California Research Center — Coronado, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (74 Sites)
Showing the first 25 of 74 sites.
- Southern California Research Center — Coronado, California
- Inland Empire Liver Foundation — Rialto, California
- Mercy Medical Center — Baltimore, Maryland
- UMass Memorial Medical Center — Worcester, Massachusetts
- Stony Brook University Cancer Clinical Trials — Stony Brook, New York
- The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui
- The First Affiliated Hospital Of Anhui Medical University — Hefei, Anhui
- The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui
- Beijing Cancer Hospital — Beijing, Beijing Municipality
- Beijing You'an Hospital, Capital Medical University — Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality
- The 900th Hospital of Joint Logistic Support Force of PLA — Fuzhou, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian
- Foshan First People's Hospital — Foshan, Guangdong
- Nanfang Hospital — Guangzhou, Guangdong
- The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine — Guangzhou, Guangdong
- Guangxi Medical University Affiliated Tumor Hospital — Nanning, Guangxi
- Hainan General Hospital - Hepatology — Haikou, Hainan
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang
- Luoyang Central Hospital — Luoyang, Henan
- Henan Cancer Hospital — Zhengzhou, Henan
- Zhengzhou University - First Affiliated Hospital — Zhengzhou, Henan
- hubei Cancer Hospital — Wuhan, Hubei
- Tongji Hospital - Medical Oncology — Wuhan, Hubei
- Hunan Cancer Hospital - Radiology — Changsha, Hunan
💰 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.
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- TheraSphere With Durvalumab and Tremelimumab for HCC — San Diego, California
- Blood Salvage in Orthotopic Liver Transplantation With HCC — Toronto, Ontario
- Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC) — Prescott Valley, Arizona
Explore by condition: All Hepatocellular Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.