Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

  • End date
    Aug 30, 2024
  • participants needed
  • sponsor
    Baocai Xing
Updated on 11 March 2021


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(TKI) for the treatment of local advanced hepatocellular carcinoma.

Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment Lenvatinib, Sintilimab
Clinical Study IdentifierNCT04042805
SponsorBaocai Xing
Last Modified on11 March 2021


Yes No Not Sure

Inclusion Criteria

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 score7
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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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