Clinical trial · Observational
Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With 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
NCT06031636CI-TRIAL-00069503unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma, Advanced | Pleural Malignant Mesothelioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncolytic Adenovirus H101 | Drug | — | UNRESOLVED |
| Programmed death receptor-1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Oncolytic adenovirus(H101) combined with PD-1 inhibitors
- description
- 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.
- interventionNames
- Drug: Oncolytic Adenovirus H101
- Drug: Programmed death receptor-1 inhibitor
Primary outcomes (2)
- measure
- ORR(Objective Response Rate)
- timeFrame
- 36 months
- description
- The proportion of CR(complete response) and PR(partial response) in all patients.
- measure
- DCR(Disease Control Rate)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.