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NCT Number: NCT06031636

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Dingkun Hou

SUB_INVESTIGATOR

Haitao Wang

PRINCIPAL_INVESTIGATOR

Haitao Wang, Ph.D

CONTACT

[email protected]

+86-022-88326385

Jinhuan Wang

SUB_INVESTIGATOR

Lei Wang

SUB_INVESTIGATOR

Lili Wang

SUB_INVESTIGATOR

Lili Wang, MM

CONTACT

[email protected]

+86-022-88326610

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years old (including boundary values), regardless of gender.
  • Confirmed as late stage MPM patients who have failed immunotherapy.
  • The patient or their legal representative can understand and sign the informed consent form.
  • 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.
  • ECOG score 0-2.

Exclusion criteria

  • Physicians participating in the study believe that patients may not be able to provide continuous follow-up information.
  • Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases).
  • Contraindications to relevant drugs (such as oncolytic adenoviruses, PD-1 inhibitors, etc.)

Treatment and study plan

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

Other names: Recombinant Human Type-5 Adenovirus

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

Primary outcomes

  1. ORR(Objective Response Rate)

    Time frame: 36 months

    The proportion of CR(complete response) and PR(partial response) in all patients.

  2. DCR(Disease Control Rate)

    Time frame: 36 months

    The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haitao Wang, Ph.D

CONTACT

[email protected]

+86-022-88326385

Jinhuan Wang, Ph.D

CONTACT

[email protected]

+86-022-88326610

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Second Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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