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

September 2, 2023 updated by: Tianjin Medical University Second Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical Unversity Second Hospital
        • Contact:
        • Sub-Investigator:
          • Lei Wang
        • Sub-Investigator:
          • Lili Wang
        • Sub-Investigator:
          • Dingkun Hou
        • Principal Investigator:
          • Haitao Wang
        • Sub-Investigator:
          • Jinhuan Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with malignantpleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
Other Names:
  • Recombinant Human Type-5 Adenovirus
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS(Progression Free Survival)
Time Frame: 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.
36 months
OS(Overall Survival)
Time Frame: 36 months
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)
Time Frame: 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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Second Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 2, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H101 for MPM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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