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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 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.
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 534 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 534 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (110% higher). The listed sponsor is CStone Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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