Clinical Trial

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

Not Yet Recruiting Phase 2
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Record status
This record was last updated March 7, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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 .
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-02-02.
Trial Details
NCT Number NCT06253598
Lead Sponsor The First Affiliated Hospital of Bengbu Medical University
Conditions Hepatocellular Carcinoma
Enrollment 30 participants
Start Date 2024-03-30
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-03-07