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ACTIVE NOT RECRUITING Phase 3

A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma

NCT04194775 · View on ClinicalTrials.gov ↗

Study Summary

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 of and lenvatinib is selected as the basic treatment for HCC.

Conditions Studied

Interventions

  • DRUG Nofazinlimab (CS1003)+Lenvatinib
  • DRUG Nofazinlimab (CS1003) Placebo+Lenvatinib

Study Locations (20)

Anhui

  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • The First Affiliated Hospital Of Anhui Medical University — Hefei
  • The Second Affiliated Hospital of Anhui Medical University — Hefei

Beijing Municipality

  • Beijing Cancer Hospital — Beijing
  • Beijing You'an Hospital, Capital Medical University — Beijing
  • Peking Union Medical College Hospital — Beijing

Guangdong

  • Foshan First People's Hospital — Foshan
  • Nanfang Hospital — Guangzhou
  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine — Guangzhou

California

  • Southern California Research Center — Coronado
  • Inland Empire Liver Foundation — Rialto

Fujian

  • The 900th Hospital of Joint Logistic Support Force of PLA — Fuzhou
  • The First Affiliated Hospital of Xiamen University — Xiamen

Maryland

  • Mercy Medical Center — Baltimore

Massachusetts

  • UMass Memorial Medical Center — Worcester

New York

  • Stony Brook University Cancer Clinical Trials — Stony Brook

Trial Details

FieldValue
Enrollment Target 534 participants
Start Date 2019-12-13
Est. Completion 2026-09-30
Phase Phase 3

Sponsor

CStone Pharmaceuticals

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04194775

The ClinicalTrials.gov registry entry for NCT04194775 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 534 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CStone Pharmaceuticals, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Nofazinlimab (CS1003)+Lenvatinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04194775 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Anhui, Beijing Municipality, Guangdong. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04194775 about?

NCT04194775 is a clinical study titled "A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma". 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 hep...

What is the current status of trial NCT04194775?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 534 participants. The study started on 2019-12-13. Estimated completion is 2026-09-30.

What conditions does trial NCT04194775 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04194775?

The interventions under investigation include: Nofazinlimab (CS1003)+Lenvatinib (DRUG), Nofazinlimab (CS1003) Placebo+Lenvatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04194775?

This trial is sponsored by CStone Pharmaceuticals, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04194775 being conducted?

This trial has 20 study locations across California, Maryland, Massachusetts, New York, Anhui. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial