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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194775
Recruitment Status : Active, not recruiting
First Posted : December 11, 2019
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Nofazinlimab (CS1003)+Lenvatinib Drug: Nofazinlimab (CS1003) Placebo+Lenvatinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nofazinlimab (CS1003) Drug: Nofazinlimab (CS1003)+Lenvatinib
Nofazinlimab (CS1003), intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily
Placebo Comparator: Nofazinlimab (CS1003) placebo Drug: Nofazinlimab (CS1003) Placebo+Lenvatinib
Nofazinlimab (CS1003) Placebo, i.v. administration every 21 days ; Lenvatinib oral administration, once daily


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) evaluated by the Blinded Independent Central Review Committee (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: up to approximately 42 months ]
  2. Overall survival (OS) [ Time Frame: up to approximately 42 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Age ≥18 years on the day of signing informed consent-(For Taiwan, the lower limit of age is 20 years).
  2. Subjects with unresectable advanced HCC, that is not eligible for surgery and/or locoregional therapy (Stage B or C based on Barcelona Clinic Liver Cancer [BCLC] staging system, and meets either one of the following criteria: 1) histologically or cytologically confirmed diagnosis of HCC, 2) clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria. Patients without cirrhosis require histological confirmation of diagnosis.
  3. With at least one measurable lesion can be assessed
  4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  5. Life expectancy ≥ 3 months.
  6. Child-Pugh A
  7. No prior systemic treatment for advanced HCC
  8. Subjects with hepatitis B virus (HBV) infection, # are willing to continue receiving antiviral treatment while on study.

  9. Subjects have adequate organ and marrow function. Female subjects with childbearing potential must have negative serum pregnancy test result at screening. Female subjects with childbearing potential, and male subjects and their female partners with childbearing potential must agree to use an contraceptive method(s) from the day of signing informed consent form (ICF), during the study and till at least 6 months after the last dose of study treatment.

    Exclusion criteria

  10. Fibrolamellar-HCC, sarcomatoid, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.
  11. A prior bleeding event due to esophageal within 6 months or other gastrointestinal bleeding events within 28 days prior to screening.
  12. Malabsorption syndrome or inability to take oral medication due to other causes.
  13. HBV and HCV co-infection.
  14. Investigator evaluates to increase the drug related risk caused by enrolling subjects in trial and taking study drug, or any serious or uncontrolled systematic disease that confound the drug absorption or the study outcome, e,g diabetes mellitus, hypertension, rheumatoid arthritis, major cardiovascular disease and so on.
  15. Surgery or locoregional therapy for palliative purpose within 4 weeks prior to study treatment.
  16. History of other malignancy(ies) in the past 5 years, except for malignant disease treated with curative intent and without active disease.
  17. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  18. Current or prior use of systemic corticosteroid (> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study treatment.
  19. History of bone marrow transplantation or organ transplantation.
  20. History of anaphylaxis or hypersensitivity to any ingredient of the investigational product.
  21. Any contraindication of lenvatinib.
  22. Known history of drugs abuse that would interfere with cooperation with the requirements of the trial.
  23. Pregnant or lactating female subjects.
  24. History of psychiatric disease that would interfere with cooperation with the requirements of the trial; lack of or with restricted physical capability.
  25. QTc interval > 470 msec (as calculated with Fridericia's formula) at screening electrocardiogram (ECG);
  26. Any condition that would in the investigator's judgment, prevent the subject from participating in this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194775


Locations
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United States, California
Southern California GI and Liver Centers
Coronado, California, United States, 92118
Inland Empire Liver Foundation
Rialto, California, United States, 92377
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Massachusetts
UMass Memorial Health
Worcester, Massachusetts, United States, 01655
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 201203
Sponsors and Collaborators
CStone Pharmaceuticals
More Information
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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04194775    
Other Study ID Numbers: CS1003-305
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action