Hepatocellular Carcinoma Clinical Trial
Official title:
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 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: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Baocai Xing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) | 1 year after the last patient's enrollment | ||
Secondary | Overall Survival | 2 years after the last patient's enrollment | ||
Secondary | Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs). | 2 years after the last patient's enrollment | ||
Secondary | Conversion rate to surgery | Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment | 1 year after the last patient's enrollment | |
Secondary | Tumor mutation burden in association with ORR and survival. | It will be performed by NGS. | 1 year after the last patient's enrollment |
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