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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.)

Treatments Being Tested

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

Locations (1)

Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China