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A Phase III Study of 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194775
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
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 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, CS1003 (or placebo) and lenvatinib are both considered as the study treatment while 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: CS1003+Lenvatinib Drug: CS1003 Placebo+Lenvatinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 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 CS1003 in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)
Estimated Study Start Date : December 30, 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: CS1003 Drug: CS1003+Lenvatinib
CS1003, intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily
Placebo Comparator: CS1003 placebo Drug: CS1003 Placebo+Lenvatinib
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 investigators 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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. 18 years -75 years of age on the day of signing informed consent.
  2. Subjects with pathohistologically or cytologically confirmed unresectable advanced HCC not eligible for locoregional therapy (Stage B or C based on Barcelona Clinic Liver Cancer [BCLC] staging system,
  3. With at least one measurable lesion 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 full function in organ or bone marrow.Female subjects with childbearing potential must have negative serum pregnancy test result at screening. Female subjects with childbearing potential except those with documented sterilization operation or post-menopausal subjects, and male subjects and their partners must agree to use an effective contraceptive 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. Fibrolamemellar carcinoma of liver, sarcomatoid carcinoma, cholangiocellular carcinoma or mixed hepatic cancer.
  11. Gastrointestinal bleeding that is active or documented within the past 6 months.
  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. Palliative surgery, locoregional therapy or radiotherapy for liver lesions within 4 weeks prior to screening.
  16. With another active malignancy in the past 5 years, except local curable cancers that have undergone curative therapy
  17. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  18. Any 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 allogenic bone marrow transplantation or organ transplantation.
  20. History of anaphylaxis or hypersensitivity to any ingredient of the investigational product.
  21. With any contraindication of lenvatinib.
  22. Subjects with known history of drugs abuse.
  23. Female subjects who are pregnant or lactating.
  24. Subjects with 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. Subjects with any condition that in the investigator's opinion are not suitable for 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


Contacts
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Contact: Wendie YUAN +86 21 61097678 cstonera@cstonepharma.com

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: December 11, 2019
Last Verified: December 2019

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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