Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Each patient eligible to participate in this study must meet all the following criteria:

‣ 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

⁃ Age\>/=18 years

⁃ Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation

⁃ No extrahepatic metastasis detected on CT chest with or without IV contrast, abdomen and pelvis with IV and oral contrast (triphasic-if feasible based on kidney function), or MRI abdomen/liver and chest CT.

⁃ Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 6 months after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days of first dose of study drug

⁃ Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 6 months after the last dose of tislelizumab. Males must agree not to donate or bank sperm during treatment with tislelizumab and for \> 6 months after treatment stop.

‣ Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1.

‣ Demonstrate adequate bone marrow and organ function as defined below:

• Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin \> 8.5 g/dL, Platelet count ≥ 75,000/mcL

∙ Renal - Serum creatinine OR calculated\* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels \> 1.5x institutional ULN

⁃ Calculate serum creatinine clearance using the standard Cockcroft-Gault formula.

• Urine protein Urine dipstick for proteinuria \< 2+ within 7 days prior to start of study treatment \*Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate \< 1g of protein in 24 hours

∙ Hepatic - Serum total bilirubin ≤ 3 mg/dL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN \*This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.

Locations
United States
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Salma Jabbour, MD
jabbousk@cinj.rutgers.edu
732-253-3961
Backup
Patrick Boland, MD
pb564@cinj.rutgers.edu
732-235-6628
Time Frame
Start Date: 2022-07-25
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 35
Treatments
Experimental: Tislelizumab in conjunction with radiation therapy
Participants will receive local therapy including TACE+ RT or Ablation (tumors with incomplete ablation) + RT or RT alone (for patients not eligible for TACE or Ablation) and will be screened for eligibility prior to enrollment.~Once eligibility has been confirmed, Tislelizumab will be started before radiation therapy and will continue after radiation therapy.~Participants who do not receive Tislelizumab for a total of two cycles will be replaced and interpreted for only toxicity analysis.
Related Therapeutic Areas
Sponsors
Collaborators: Natera, Inc., BioGene Pharmaceutical Ltd.
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov