Clinical trial NCT04042805: Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
Official title: Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 1 year after the last patient's enrollment
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years after the last patient's enrollment
measure: Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).
timeFrame: 2 years after the last patient's enrollment
measure: Conversion rate to surgery
timeFrame: 1 year after the last patient's enrollment
measure: Tumor mutation burden in association with ORR and survival.
timeFrame: 1 year after the last patient's enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Baocai Xing, Doctor
role: PRINCIPAL_INVESTIGATOR
References: