Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05366829
Phase
PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Hepatocellular
  • Liver Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 25, 2022
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Safety as assessed by number of participants experiencing adverse events [ Time Frame: 48 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Salma Jabbour, MD
[email protected]
732-253-3961
Montefiore Medical CenterThe BronxNew York10451
Nitin Ohri, MD
[email protected]
516-672-2711

Find similar trials in New Brunswick, NJ

By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJMontefiore Medical Center· The Bronx, NY

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