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
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age 18-75 years old (including boundary values), regardless of gender.
• Confirmed as late stage MPM patients who have failed immunotherapy.
• The patient or their legal representative can understand and sign the informed consent form.
• At least one lesion that can safely undergo intratumoral injection or intrapleural injection of oncolytic adenovirus as the target lesion, with a diameter of spiral CT ≥ 1cm or ordinary CT ≥ 2cm, and can be measured through imaging methods.
• ECOG score 0-2.
Locations
Other Locations
China
Tianjin Medical Unversity Second Hospital
RECRUITING
Tianjin
Contact Information
Primary
Haitao Wang, Ph.D
peterrock2000@126.com
+86-022-88326385
Backup
Jinhuan Wang, Ph.D
wjhhappy2008@163.com
+86-022-88326610
Time Frame
Start Date: 2023-07-20
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 15
Treatments
Oncolytic adenovirus(H101) combined with PD-1 inhibitors
This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Second Hospital