NCT06031636

Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma

Observation of the Efficacy and Safety of Oncolytic Adenovirus Injection Combined With Programmed Death Receptor Inhibitors in Treatment of Advanced Malignant Pleural Mesothelioma : a Single Center, Prospective, Case Registration Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Oncolytic Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

Detailed description

By monitoring the clinical symptoms of patients with advanced immune resistant pleural mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1) inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the drug, and finally evaluate the quality of life of patients using oncolytic adenovirus injection(H101) combined with PD-1 inhibitors.

Conditions

• Malignant Pleural Mesothelioma, Advanced

Interventions

Type	Name	Description
DRUG	Oncolytic Adenovirus H101	The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles
DRUG	Programmed death receptor-1 inhibitor	The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles

Timeline

• Start date: 2023-07-20
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-09-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: China