Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
NCT ID: NCT04042805
Last Updated: 2021-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
36 participants
INTERVENTIONAL
2019-08-01
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sintilimab Plus Lenvatinib
Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Sintilimab
200mg intravenously every 3 weeks
Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
Interventions
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Sintilimab
200mg intravenously every 3 weeks
Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery
* No previous systemic anticancer treatment or TACE treatment
* Age ≥18 years
* ECOG performance status: 0-1
* Child Pugh score≤7
* Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1
* Life expectancy ≥12 weeks.
* Patients must be able to understand and willing to sign a written informed consent document
Exclusion Criteria
* History of hepatic encephalopathy or liver transplantation
* Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.
* Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity
* With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable.
* Evidence of active pulmonary tuberculosis (TB).
* Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
* History of allergic reactions to related drugs
* Pregnant women, nursing mothers
18 Years
100 Years
ALL
No
Sponsors
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Baocai Xing
OTHER
Responsible Party
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Baocai Xing
Professor
Principal Investigators
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Baocai Xing, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019088
Identifier Type: -
Identifier Source: org_study_id
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