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

Recruiting

• Conditions: Malignant Pleural Mesothelioma, Advanced
• Interventions: Drug: Oncolytic Adenovirus H101; Drug: Programmed death receptor-1 inhibitor

• Registration Number: NCT06031636
• Lead Sponsor: Tianjin Medical University Second Hospital

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.

Study Timeline

• Study Start: 2023-07-20
• Status Verified: 2023-09
• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-02
• Last Update Submitted: 2023-09-02
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oncolytic adenovirus(H101) combined with PD-1 inhibitors	Oncolytic Adenovirus H101	This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.
Oncolytic adenovirus(H101) combined with PD-1 inhibitors	Programmed death receptor-1 inhibitor	This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.

Primary Outcome Measures

Name	Time	Method
ORR(Objective Response Rate)	36 months	The proportion of CR(complete response) and PR(partial response) in all patients.
DCR(Disease Control Rate)	36 months	The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.

Secondary Outcome Measures

Name	Time	Method
PFS(Progression Free Survival)	36 months	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.
AEs(Adverse Events)	36 months	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.
OS(Overall Survival)	36 months	Time between the date of grouping and death from any cause or the end of the last follow-up visit.

Trial Locations

Locations (1)

Tianjin Medical Unversity Second Hospital; 🇨🇳 Tianjin, Tianjin, China