drugset / Trial / NCT06253598

Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma

NCT06253598

Phase 2 Not yet recruiting 30 enrolled The First Affiliated Hospital of Bengbu Medical University
NaSingle-groupOpen-labelTreatment

Summary

This prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. The recombinant human adenovirus type 5 was administered intratumorally on day 1 and 5 in cycle 1 and cycle 2. Lenvatinib was administered orally once daily started on day 1 of cycle 1 .Tislelizumab was administered intravenously every 3 week started on day 1 of cycle 3. The patient accepted the therapy until disease progression or unacceptable toxicity occurred or meet the end point of the study. The primary end point was ORR assessed by investigator using RECIST v1.1 .

Timeline

Start
2024-03-30
Primary completion
2025-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject H101 Other / unclassified 1e+12 unknown Other
Subject H101 Other / unclassified 1.5e+12 unknown Other
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous