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

Malignant Pleural Mesothelioma, Advanced Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031636
• Other study ID #: H101 for MPM
• Status: Recruiting
• Start date: July 20, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: September 2023
• Source: Tianjin Medical University Second Hospital
• Contact: Haitao Wang, Ph.D
• Phone: +86-022-88326385
• Email: peterrock2000[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.)

Related Conditions & MeSH terms

• Adenoviridae Infections
• Malignant Pleural Mesothelioma, Advanced
• Mesothelioma
• Mesothelioma, Malignant

Intervention

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
• 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

Country	Name	City	State
China	Tianjin Medical Unversity Second Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(Objective Response Rate)	The proportion of CR(complete response) and PR(partial response) in all patients.	36 months
Primary	DCR(Disease Control Rate)	The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.	36 months
Secondary	PFS(Progression Free Survival)	Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST version1.1.	36 months
Secondary	OS(Overall Survival)	Time between the date of grouping and death from any cause or the end of the last follow-up visit.	36 months
Secondary	AEs(Adverse Events)	Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded.	36 months