A Prospective, Two-arm, Randomized，Phase II Clinical Study of Sintilimab Combined With Lenvatinib Versus Hepatic Artery Infusion Chemotherapy for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma With a High Risk of Recurrence.

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country60 target enrollmentAugust 23, 2022

ConditionsResectable Hepatocellular Carcinoma

InterventionsSintilimab and Lenvatinib HAIC-FOLFOX

DrugsSintilimab and Lenvatinib HAIC-FOLFOX

Overview

Phase: Phase 2
Intervention: Sintilimab and Lenvatinib
Conditions: Resectable Hepatocellular Carcinoma
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: 1-year DFS%
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, Two-arm, randomized，phase II clinical study of Sintilimab Combined With Lenvatinib Versus HAIC for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.

Registry

clinicaltrials.gov

Start Date

August 23, 2022

End Date

September 1, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients volunteered to participate in this study and signed informed consent;
•Age 18-75, male or female;
•ECOG PS score 0-1;
•Child-pugh liver function grading: Grade A
•The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to the indications for resectable operation in the Guidelines for diagnosis and Treatment of HCC (2019) edition;
•According to the preoperative evaluation of the researcher, the patient had a high risk of recurrence and met at least one of the risk factors:
•b: 2-3 tumors with the maximum diameter ≤3cm; IIa: tumor 2-3,biggest \> 3 cm in diameter
•According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
•Expected survival ≥ 6 months;
•The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) ;

Exclusion Criteria

•Have received radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapies before;
•Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma; Active malignancies other than HCC within 5 years or concurrently;
•Having hypertension that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous history of hypertension crisis or hypertensive encephalopathy;
•Subject has previous or concurrent malignancies (except cured basal cell carcinoma of skin and carcinoma in situ of the cervix);
•Previous treatment with Tislelizumab or other PD-1/PD-L1 treatment could not be enrolled; Subjects are known to have prior allergies to macromolecular protein reparations or to any Tislelizumab or Lenvatinib excipients;
•Subject has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma have been completely relieved and may be included as adults without any intervention; Asthma requiring medical intervention with bronchodilators will not be included);
•Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (\>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment;
•Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage;
•Clinical symptoms or diseases of the heart that are not well controlled, such as:
•NYHA2 or above heart failure Unstable angina pectoris Myocardial infarction occurred within 1 year