Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042805
• Other study ID #: 2019088
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2021
• Source: Beijing Cancer Hospital
• Contact: Baocai Xing, Doctor
• Phone: +8613910721238
• Email: xingbaocai88[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• Sintilimab
200mg intravenously every 3 weeks

Drug:
• Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Baocai Xing

Country where clinical trial is conducted

China, 

Outcome

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