Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
- Registration Number
- NCT04042805
- Lead Sponsor
- Baocai Xing
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sintilimab Plus Lenvatinib Sintilimab 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. Sintilimab Plus Lenvatinib Lenvatinib 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 1 year after the last patient's enrollment
- Secondary Outcome Measures
Name Time Method Overall Survival 2 years after the last patient's enrollment Tumor mutation burden in association with ORR and survival. 1 year after the last patient's enrollment It will be performed by NGS.
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
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
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China