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NCT04194775 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Hepatocellular Carcinoma, sponsored by CStone Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
534
Enrollment target
20
Study locations

NCT04194775: Active Phase 3 study of Hepatocellular Carcinoma, sponsored by CStone Pharmaceuticals.

NCT04194775 is a Phase 3 study of Hepatocellular Carcinoma that is active but no longer recruiting, run by CStone Pharmaceuticals. The registered enrollment target is 534 participants, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04194775, a Phase 3 study of Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by CStone Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
534 participants
Enrollment target
20
Study locations

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.

Primary Outcome

OS was defined as the time interval between the date of randomization to the date of death from any cause.

Conditions Studied

Hepatocellular Carcinoma

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
CStone Pharmaceuticals

4 total trials

What the registry record for NCT04194775 still lists

NCT04194775 is an interventional study that assigns participants to a tested intervention. The registered 534 participants enrollment target is mid-sized for trials with a published cap, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (110% higher).

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.

NCT04194775 names 20 study sites across 12 states, led by Anhui, Beijing Municipality, Guangdong.

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.

What interventions are being tested in trial NCT04194775?

The interventions under investigation include: Nofazinlimab (CS1003)+Lenvatinib (DRUG), Nofazinlimab (CS1003) Placebo+Lenvatinib (DRUG).

Who is sponsoring clinical trial NCT04194775?

This trial is sponsored by CStone Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Hepatocellular Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04194775's enrollment target sits among peer trials

534 25th of 145 higher than 121 of 145 other Hepatocellular Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04194775, the US trial registry maintained by the National Library of Medicine. NCT04194775 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.