Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

About this trial

The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic disease and improve one year progression-free survival rates for participants and optimize local control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted

Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5

Eastern Cooperative Oncology Group performance status score of 0-2

Disqualifiers

Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields

Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time

Severe, active co-morbidity as per investigator

More than five discrete intrahepatic parenchymal foci of definite HCC or left/right or main portal vein thrombus

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab (also known as BGB A317) is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against programmed cell death protein-1 (PD-1) under clinical development for the treatment of several human malignancies. Tislelizumab consolidation therapy after radiation therapy can capitalize on the immunomodulatory effect of radiotherapy and improve tumor responses and patient outcomes.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Tislelizumab in conjunction with radiation therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety as assessed by number of participants experiencing adverse events

Number of participants experiencing adverse events grade three or higher, as defined by Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). Severity is a measure of intensity (eg, grade of a specific AE, mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], or life-threatening \[Grade 4\]), whereas seriousness is classified by the criteria based on the regulatory definitions. Seriousness serves as the guide for defining regulatory reporting obligations from the Investigator Sponsor to applicable regulatory authorities as described in CTCAE version 5.0.

Time frame
48 months

Secondary outcomes

1

Response and progression will be evaluated in this trial using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (v1.1).

Changes in only the largest diameter (uni dimensional measurement) of the tumor lesions are used in the RECIST criteria. Measurable Disease: Tumor lesions: Must be accurately measured in at least 1 dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of: * 10 mm by CT scan (irrespective of scanner type) and MRI (no less than double the slice thickness and a minimum of 10 mm) * 10 mm caliper measurement by clinical exam (when superficial) * 20 mm by chest X ray (if clearly defined and surrounded by aerated lung) Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm). At baseline and in follow up, only the short axis will be measured and followed.

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

BioGene Pharmaceutical Ltd.

Collaborator

Natera, Inc.

Collaborator