Status:
UNKNOWN
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
Lead Sponsor:
Baocai Xing
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(...
Eligibility Criteria
Inclusion
- Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
- 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
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04042805
Start Date
August 1 2019
End Date
August 30 2024
Last Update
March 2 2021
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142