Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: BioGene Pharmaceutical Ltd.; Natera, Inc.

Criteria

Inclusion Criteria:

• Have provided signed informed consent for the trial

• Aged ≥18 years at the time of informed consent

• Histologic proof of malignancy

• Radiologic or histologic evidence of bone metastases or non-bone metastases

• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3

• Pain Score ≥ 3

• Life expectancy of six months or more

• Willing and able to comply with all aspects of the protocol

• A female participant is eligible to participate if she is not pregnant and not breastfeeding

• Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.

• A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment

Exclusion Criteria:

• Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)

• Spinal metastasis

• Active compression of spinal cord/cauda equina

• Previous RT or SBRT to the same site

• > 3 sites requiring radiation treatment