Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

Baocai Xing

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lenvatinib; Biological: Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04042805

2019088

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Sintilimab Plus Lenvatinib

Experimental group

Description:

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.

Treatment:

Biological: Sintilimab

Drug: Lenvatinib