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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncolytic adenovirus(H101) combined with PD-1 inhibitors | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncolytic Adenovirus H101 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective Response Rate) | The proportion of CR(complete response) and PR(partial response) in all patients. | 36 months |
| DCR(Disease Control Rate) | The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| OS(Overall Survival) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with malignantpleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haitao Wang, Ph.D | Contact | +86-022-88326385 | peterrock2000@126.com | |
| Jinhuan Wang, Ph.D | Contact | +86-022-88326610 | wjhhappy2008@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical Unversity Second Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| Programmed death receptor-1 inhibitor | Drug | 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 |
|
Time between the date of grouping and death from any cause or the end of the last follow-up visit. |
| 36 months |
| 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 |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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