Rutgers, The State University of New Jersey
Salma Jabbour, MD
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.
Carcinoma, Hepatocellular
Liver Cell Carcinoma
Tislelizumab
Phase 2
Primary Objective: To determine if consolidation therapy with Tislelizumab following local therapy improves one year progression-free survival in patients with locally advanced, unresectable Hepatocellular carcinoma ( HCC). Progression-free survival (PFS) is defined as the time from first administration of Tislelizumab until the criteria for disease progression is met by response evaluation criteria in solid tumors (RECIST)1.1 or death as a result of any cause, whichever occurs first. Secondary Objectives: To determine if consolidation therapy with Tislelizumab after definitive therapy improves time to metastatic disease and overall survival (OS) in subjects with localized, inoperable Hepatocellular carcinoma (HCC). To assess objective response rate, disease control rate, duration of response with consolidation therapy with Tislelizumab after local therapy in subjects with localized, inoperable Hepatocellular carcinoma (HCC). To assess the safety profile of Tislelizumab after definitive therapy. To assess biomarker response as measured by Alpha fetoprotein (AFP), should the patient's tumor produce AFP. Exploratory objectives: To determine the association of the tumor molecular profile from next-generation sequencing (NGS), of the tissue prior to the initiation of therapy with the treatment response. To analyze Circulating tumor DNA (ct DNA) as a biomarker of response to therapy and early detection of disease progression.
Study Type : | Interventional |
Estimated Enrollment : | 35 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma |
Actual Study Start Date : | July 25, 2022 |
Estimated Primary Completion Date : | June 1, 2027 |
Estimated Study Completion Date : | June 1, 2027 |
Arm | Intervention/treatment |
---|---|
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. |
Drug: Tislelizumab |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Recruiting
Montefiore Medical Center
Bronx, New York, United States, 10451