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Tyrosine Kinase Inhibitor
Toripalimab + Lenvatinib for Liver Cancer
Phase 3
Waitlist Available
Research Sponsored by Shanghai Junshi Bioscience Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No previous use of any systemic therapy for HCC (mainly including systemic chemotherapy, antiangiogenic drugs or other molecular targeted therapy, immunotherapy containing CTLA-4, PD 1/PD-L1 monoclonal antibody)
Female subjects at childbearing age must receive serum pregnancy test within 7 days before randomization, have negative result, and are willing to use reliable and effective contraceptive methods during the trial and within 60 days after last administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is more effective and has fewer side effects than the current standard of care.
Who is the study for?
Adults aged 18-75 with advanced liver cancer (HCC), who haven't had systemic treatments for HCC, can join this trial. They should be in relatively good health (ECOG score 0-1) and have a life expectancy of at least 12 weeks. Women must test negative for pregnancy and use birth control, as must men if their partners can bear children.Check my eligibility
What is being tested?
The study is testing the effectiveness of Toripalimab combined with Lenvatinib versus a placebo combined with Lenvatinib in treating advanced liver cancer. Participants are randomly assigned to either the experimental group or control group in a ratio of 2:1.See study design
What are the potential side effects?
Possible side effects include allergic reactions to monoclonal antibodies or anti-angiogenesis drugs, gastrointestinal issues like ulcers or bleeding, increased risk of infection, and potential heart or lung problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not used any drug treatments for my liver cancer.
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I am not pregnant, can take a pregnancy test, and will use birth control during and after the trial.
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My liver function is relatively good and I've never had brain issues due to liver disease.
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My liver cancer diagnosis is confirmed by tests or I have cirrhosis and meet the AASLD criteria for liver cancer.
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My liver cancer is at an intermediate or advanced stage and cannot be treated with surgery.
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I am fully active or can carry out light work.
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I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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
DCR
Duration of Response (DOR)
Immunogenicity
+7 moreOther outcome measures
Assessment of the correlation between tumor cell PD-L1 expression level/ percentage and efficacy
Tumor mutation burden (TMB)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental groupExperimental Treatment1 Intervention
Toripalimab combined with Lenvatinib
Group II: Control groupPlacebo Group1 Intervention
Placebo combined with Lenvatinib
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Who is running the clinical trial?
Shanghai Junshi Bioscience Co., Ltd.Lead Sponsor
112 Previous Clinical Trials
26,713 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I haven't had a blood transfusion or taken blood cell-boosting drugs in the last 14 days.I have not used any drug treatments for my liver cancer.I am not pregnant, can take a pregnancy test, and will use birth control during and after the trial.I have at least one tumor that can be measured and has not been treated before, or it's in a previously treated area but has grown.I cannot swallow pills or have a condition that affects how my body absorbs food or medicine.I haven't had liver cancer treatment or used specific Chinese medicines in the last 4 weeks.I do not have brain or spinal cord cancer spread, confirmed by MRI.I have a specific type of liver cancer.My liver function is relatively good and I've never had brain issues due to liver disease.My hepatitis B viral load is low and I am on or will start antiviral therapy.My liver cancer diagnosis is confirmed by tests or I have cirrhosis and meet the AASLD criteria for liver cancer.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't had serious bleeding in my stomach or intestines in the last 6 months.I have not had tuberculosis or TB treatment in the last year.I am not on any strong infection treatments right now, except for viral hepatitis.I have previously used immunotherapy targeting PD-1/PD-L1.My liver cancer is at an intermediate or advanced stage and cannot be treated with surgery.I will use effective birth control during and for 60 days after the trial.I do not have uncontrolled fluid buildup in my chest or abdomen that requires draining.I am not on long-term steroids or immunosuppressive therapy.I haven't had major surgery in the last 4 weeks, except for a biopsy.You are expected to live for at least 12 more weeks.I am fully active or can carry out light work.I haven't had cancer, except for certain skin, cervical, or prostate cancers, in the last 5 years.My cancer has spread to major blood vessels near my heart according to scans.I am between 18 and 75 years old.I currently have a severe fistula.I am allergic to certain cancer drugs or monoclonal antibodies.I have a serious wound, ulcer, or untreated bone fracture.I have had lung issues not caused by infection, except if due to radiotherapy.I do not have serious heart or brain blood vessel diseases.I have had a transplant of stem cells or an organ from another person.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental group
- Group 2: Control group
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.
Does this research allow for subjects that are above the age of 25?
"This particular clinical trial is only open to patients that are between 18-75 years old."
Answered by AI
Could you explain what health risks are associated with being in the Experimental group?
"Given that this is a Phase 3 study with evidence of efficacy and safety from multiple rounds of testing, our team rates the safety of the experimental group as a 3."
Answered by AI
Which type of patient would be best suited for this trial?
"Patients with carcinoma or hepatocellular who are between 18 and 75 years old may be eligible for this study, of which 519 are being recruited."
Answered by AI
Is this research still looking for individuals to participate?
"The clinical trial is presently searching for patients. The clinical trial was first posted on 6/29/2020 and was most recently updated on 5/22/2022."
Answered by AI
What other research has been done on the efficacy of this treatment?
"There are currently 307 clinical trials underway for the experimental group, with 51 of those in Phase 3. The experimental group's trials are mostly located in Nanning, Guangxi, but there are 5509 locations for trials in total."
Answered by AI
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