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Monoclonal Antibodies
Nofazinlimab + Lenvatinib for Liver Cancer
Phase 3
Waitlist Available
Research Sponsored by CStone Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Child-Pugh A
Must not have
Malabsorption syndrome or inability to take oral medication due to other causes
Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is studying if CS1003, in combination with lenvatinib, is more effective than lenvatinib alone in treating patients with unresectable advanced hepatocellular carcinoma who have not received any prior systemic treatment.
Who is the study for?
Adults with advanced hepatocellular carcinoma (HCC) who haven't had systemic treatment and can't have surgery or locoregional therapy. They should be in relatively good health, not pregnant, agree to use contraception, and have no history of certain cancers or serious diseases that could affect the trial's outcome.
What is being tested?
The study is testing Nofazinlimab combined with Lenvatinib versus a placebo combined with Lenvatinib in treating HCC. Participants are randomly assigned to either group in this double-blind phase III trial to compare effectiveness and safety.
What are the potential side effects?
Potential side effects may include immune-related reactions due to Nofazinlimab, as well as fatigue, high blood pressure, loss of appetite from Lenvatinib. Side effects vary by individual and some may experience more severe issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer cannot be removed by surgery and is in an advanced stage.
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My liver functions well despite my illness.
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I have not received any systemic treatment for advanced liver cancer.
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I have hepatitis B and will continue my antiviral treatment during the study.
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I am fully active or can carry out light work.
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My organs and bone marrow are functioning well.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take pills because my body doesn't absorb nutrients well or for another reason.
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I have been diagnosed with HIV/AIDS.
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I have had a bone marrow or organ transplant.
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My liver cancer is of a specific rare type.
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I do not have a psychiatric condition that would prevent me from following the trial's requirements.
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I have no known allergies or adverse reactions to lenvatinib.
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I have had bleeding from my esophagus in the last 6 months or other stomach/intestine bleeding in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nofazinlimab (CS1003)Experimental Treatment1 Intervention
Group II: Nofazinlimab (CS1003) placeboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
CStone PharmaceuticalsLead Sponsor
26 Previous Clinical Trials
3,307 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take pills because my body doesn't absorb nutrients well or for another reason.I am at least 18 years old (20 if I'm in Taiwan).I have been diagnosed with HIV/AIDS.I had surgery or local therapy for symptom relief within the last 4 weeks.My liver cancer cannot be removed by surgery and is in an advanced stage.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am not pregnant and agree to use birth control during and 6 months after the study.I have had cancer in the past 5 years but was treated with the intent to cure and currently have no active disease.You have a history of drug abuse that may make it difficult for you to follow the trial's requirements.I have had a bone marrow or organ transplant.You have had a severe allergic reaction or sensitivity to any ingredient in the study medication.My liver cancer is of a specific rare type.My liver functions well despite my illness.I do not have any serious illnesses that could affect the study drug's safety or results.I do not have a psychiatric condition that would prevent me from following the trial's requirements.I have not received any systemic treatment for advanced liver cancer.I have hepatitis B and will continue my antiviral treatment during the study.I am fully active or can carry out light work.My organs and bone marrow are functioning well.I have no known allergies or adverse reactions to lenvatinib.I have had bleeding from my esophagus in the last 6 months or other stomach/intestine bleeding in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Nofazinlimab (CS1003)
- Group 2: Nofazinlimab (CS1003) placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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