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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |