Clinical trial NCT06031636: Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Pleural Mesothelioma, Advanced
Keywords: Malignant Pleural Mesothelioma, Advanced
Oncolytic Adenovirus
Programmed Death Receptor
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignantpleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

Brief 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.

Detailed 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 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.)

Primary outcomes:
measure: ORR(Objective Response Rate)
timeFrame: 36 months
measure: DCR(Disease Control Rate)
timeFrame: 36 months
Secondary outcomes:
measure: PFS(Progression Free Survival)
timeFrame: 36 months
measure: OS(Overall Survival)
timeFrame: 36 months
measure: AEs(Adverse Events)
timeFrame: 36 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical Unversity Second Hospital
state: Tianjin
Study officials:
References: