Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
Overview
- Phase
- Phase 2
- Sponsor
- Baocai Xing
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Sintilimab Plus 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.
Intervention: Sintilimab (Biological)
Sintilimab Plus 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.
Intervention: Lenvatinib (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: 1 year after the last patient's enrollment
Secondary Outcomes
- 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)
- Conversion rate to surgery(1 year 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)
Investigators
Baocai Xing
Professor
Peking University Cancer Hospital & Institute