A Prospective, One-arm, Phase II Clinical Study of Tislelizumab Combined With Lenvatinib for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma With a High Risk of Recurrence.

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country30 target enrollmentApril 30, 2021

ConditionsResectable Hepatocellular Carcinoma

InterventionsTislelizumab combined with Lenvatinib

DrugsTislelizumab combined with Lenvatinib

Overview

Phase: Phase 2
Intervention: Tislelizumab combined with Lenvatinib
Conditions: Resectable Hepatocellular Carcinoma
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Safety as measured by the number of grade 3 and grade 4 adverse events that occurred when subjects participated in the study, as defined by CTCAE v5.0.
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, one-arm, phase II clinical study of Tislelizumab combined with Lenvatinib for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.

Registry

clinicaltrials.gov

Start Date

April 30, 2021

End Date

April 30, 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

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:
•Ⅰb: a single tumor diameter \> 6.5 cm (except Mr Tian Bangxiong inflating),2-3 tumors with the maximum diameter ≤3cm;
•a : tumor 2-3,biggest \> 3 cm in diameter
•b: tumor 4 or higher
•a: vascular invasion to the naked eyes;

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

Arms & Interventions

Tislelizumab combined with Lenvatinib

Intervention: Tislelizumab combined with Lenvatinib

Outcomes

Primary Outcomes

Safety as measured by the number of grade 3 and grade 4 adverse events that occurred when subjects participated in the study, as defined by CTCAE v5.0.

Time Frame: 36 months

Feasibility as measured by rate of enrollment

Time Frame: 3 months

It's defined as a delay of surgery for any reason no more than 49 days compared to the specified planned surgery time (i.e., delay of surgery ≤42 days and scheduled surgery for 7 days).