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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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.)

Study details
    Malignant Pleural Mesothelioma
    Advanced

NCT06031636

Tianjin Medical University Second Hospital

27 January 2024

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