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

Tianjin Medical University Second Hospital

Status: Enrolling

Conditions: Malignant Pleural Mesothelioma, Advanced

Treatments: Drug: Programmed death receptor-1 inhibitor; Drug: Oncolytic Adenovirus H101

Study type: Observational

Funder types: Other

Identifiers

NCT06031636

H101 for MPM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-75 years old (including boundary values), regardless of gender.
2. Confirmed as late stage MPM patients who have failed immunotherapy.
3. The patient or their legal representative can understand and sign the informed consent form.
4. 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.
5. ECOG score 0-2.

Exclusion criteria

1. Physicians participating in the study believe that patients may not be able to provide continuous follow-up information.
2. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases).
3. Contraindications to relevant drugs (such as oncolytic adenoviruses, PD-1 inhibitors, etc.)

Trial design

15 participants in 1 patient group

Oncolytic adenovirus(H101) combined with PD-1 inhibitors

Description:

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.

Treatment:

Drug: Programmed death receptor-1 inhibitor

Drug: Oncolytic Adenovirus H101