Neoadjuvant Immunotherapy With Anti-PD1 in Borderline Resectable Hepatocellular Carcinoma

Dr Tan-to CHEUNG1 site in 1 country20 target enrollmentJuly 3, 2020

ConditionsHepatocellular Carcinoma HCC Liver Cancer

InterventionsNivolumab Hepatectomy

DrugsNivolumab

Overview

Phase: Phase 2
Intervention: Nivolumab
Conditions: Hepatocellular Carcinoma
Sponsor: Dr Tan-to CHEUNG
Enrollment: 20
Locations: 1
Primary Endpoint: Pathological tumour response rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 2, single-arm trial designed to assess the clinical benefit of treatment with nivolumab administered in patients with untreated, borderline resectable HCC.

Registry

clinicaltrials.gov

Start Date

July 3, 2020

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dr Tan-to CHEUNG

Responsible Party

Sponsor Investigator

Principal Investigator

Dr Tan-to CHEUNG

Clinical Associate Professor

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent form prior to the screening procedures.
•Age ≥ 18 years.
•Histological proof of HCC.
•Willingness to undergo a pre-dosing fresh tumour biopsy. Patients for whom fresh biopsy may not be feasible will be ineligible for enrollment.
•Intermediate or locally-advanced HCC (according to HKLC tumour status categorization) with the option of resection for potential cure as assessed by surgeon.
•Child-Pugh score ≤ 7 with no symptomatic ascites or ascites requiring therapeutic paracentesis.
•ECOG performance status ≤
•Life expectancy of ≥ 12 weeks.
•Adequate organ function (blood transfusion or use of biologic response modifiers is not permitted).
•Measurable disease according to RECIST v1.

Exclusion Criteria

•Patients who have history of organ transplantation.
•History of allergy or hypersensitivity to study drug components.
•Patients who have active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition adequately treated with hormonal replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger or deemed by the investigator not to affect safety assessment.
•Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
•Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-regulatory pathways).
•Receipt of any cancer therapy in the pre-operative period.
•Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicine) intended for general health support or to treat the disease under study within 2 weeks prior to treatment.
•Active, acute, or chronic clinically significant infections requiring therapy with the exception of hepatitis B or C virus infection. Patients with chronic HBV infection must be on antiviral therapy and have HBV DNA \< 500 IU/ml. Active or chronic co-infection with hepatitis B and C, or hepatitis B and D is not allowed.
•Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
•Symptomatic congestive heart failure, defined as ≥ Class II of the New York Heart Association functional classification system or known LVEF \< 50% at baseline.