Combining Oncolytic Adenovirus with PD-1 Inhibitors for 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
This study is testing if a new virus treatment combined with PD-1 inhibitors can help people with advanced malignant pleural mesothelioma who didn't respond to previous PD-1 treatments feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Second Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06031636 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of Oncolytic Adenovirus H101 in combination with PD-1 inhibitors in patients with advanced malignant pleural mesothelioma who have previously shown resistance to PD-1 inhibitors. It involves monitoring clinical symptoms and analyzing the effectiveness of this combination therapy. The study also aims to explore factors influencing the reversal of immune resistance in these patients and assess the overall quality of life following treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with late-stage malignant pleural mesothelioma who have failed prior immunotherapy.
Not a fit: Patients with severe comorbidities or contraindications to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced malignant pleural mesothelioma who have not responded to existing therapies.
How similar studies have performed: While the combination of oncolytic viruses and PD-1 inhibitors is a novel approach, similar studies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical Unversity Second Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Haitao Wang, Ph.D
- Email: peterrock2000@126.com
- Phone: +86-022-88326385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.