Hepatocellular Carcinoma
Conditions
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.
Interventions
BIOLOGICALSintilimab
200mg intravenously every 3 weeks
DRUGLenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
Sponsors
Baocai Xing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | 1 year after the last patient's enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years after the last patient's enrollment | — |
| 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 | — |
| Conversion rate to surgery | 1 year after the last patient's enrollment | Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment |
| Tumor mutation burden in association with ORR and survival. | 1 year after the last patient's enrollment | It will be performed by NGS. |
Countries
China
Contacts
Primary ContactBaocai Xing, Doctor
Outcome results
None listed