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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up expected to be 5.5 years after the first patient is enrollment.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ expected to be 5.5 years after the first patient is enrollment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~expected to be 5.5 years after the first patient is enrollment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Disease control rate (DCR) evaluated by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
Disease control rate (DCR) evaluated by investigators based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
Duration of response (DoR) evaluated by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nofazinlimab (CS1003)Experimental Treatment1 Intervention
Group II: Nofazinlimab (CS1003) placeboPlacebo Group1 Intervention
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Who is running the clinical trial?
CStone PharmaceuticalsLead Sponsor
26 Previous Clinical Trials
3,447 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I fit the screening criteria to become a test subject for this experiment?
"This study is looking for 534 individuals who have carcinoma and are between 18-75 years old."
Answered by AI
Has the FDA cleared CS1003+Lenvatinib for patient use?
"CS1003+Lenvatinib falls into the category of a Phase 3 trial, which means that while there is some data supporting efficacy, there is also multiple rounds of safety data. Therefore, our team at Power has rated this medication as being safe."
Answered by AI
Where is this trial being run and how many patients are enrolled?
"At the moment, this trial is being conducted at 5 different sites. 3 of those locations are in Rialto, Worcester and Coronado. The other 2 cities have not been named but enrolling at a location near you should help cut down on travel time and expenses."
Answered by AI
Does this research accept people who are not yet 20 years old?
"The aim of this study is to enroll patients that fall in the age bracket of 18 years old to 75 years old."
Answered by AI
Could you please tell me what other similar clinical trials to CS1003+Lenvatinib have been completed?
"Currently, 155 studies are investigating the effects of CS1003+Lenvatinib with 32 of them being in Phase 3. Although a few research centres for CS1003+Lenvatinib are based in Iowa City, Iowa, there are 5018 locations running clinical trials for this medication globally."
Answered by AI
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