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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04042805
Other study ID # 2019088
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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