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Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04771676
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Peng Wang, Fudan University

Study Description
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Brief Summary:
Assessment of effectiveness and local immune activation of Oncolytic Viruses H101 in patients with refractory malignant ascites.

Condition or disease Intervention/treatment Phase
Refractory Malignant Ascites Drug: Oncorine (H101) Phase 2

Detailed Description:
This study is to evaluate the effectiveness of local immune activation, and safety in patients with refractory malignant ascites after Intraperitoneal injection of oncolytic Viruses H101.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites
Actual Study Start Date : March 5, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Viral Infections

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oncorine (H101)
H101 diluted in 5ml 0.9% sodium chloride solution in was then intraperitoneally injected through the drainage catheter, the injection dose of H101 was determined by the ascites volume [5.0×10^11 vp for a small amount, 1×10^12 vp - 1.5×10^12 vp for medium amount, and 2×10^12 vp for the massive amount (classification of the ascites amount was described in response evaluation)]. H101 was injected at day 1 and 3.
 Drug: Oncorine (H101)
A modified human recombinant type 5 adenovirus with genetic modifications.


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: at four weeks after injection ]
    The objective response rate (ORR) was calculated as a summed ratio of patients with disappeared and decreased ascites to the total number of patients.

  2. Change from baseline local immune effects after H101 intraperitoneal injections [ Time Frame: at baseline, 3-, 7, 14 days after injection ]
    Detection of increased local immune activation in malignant ascites will be assessed by single cell sequencing and Mass Cytometry (CyTOF).


Secondary Outcome Measures :
  1. Systemic immune response [ Time Frame: at baseline, 3-, 7, 14 days after injection ]
    Detection of increased systemic immune Response markers in peripheral blood mononuclear cells by CyTOF.

  2. Analysis of adverse events [ Time Frame: At day 3, 7 and 14 ]

    Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

    All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained.
  • Age ≥ 18 years at time of study entry.
  • Cytologically diagnosed solid tumor malignancy.
  • Malignant peritoneal ascites confirmed by peritoneal brush cytology.
  • Failures from chemotherapy against malignant ascites.
  • Cooperative Oncology Group-Status (ECOG Status) 0 or 1

Exclusion Criteria:

  • History or evidence of active autoimmune disease that requires systemic treatment.
  • Acute or chronic active Hepatitis B or C infection or HIV infection.
  • Previous (<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.
  • Concurrent severe illness such as active infection.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771676


Contacts
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Contact: Peng Wang, MD 86-21-64175590 wangp413@163.com

Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Peng Wang, MD    86-21-64175590    wangp413@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Peng Wang, MD Fudan University
More Information
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Responsible Party: Peng Wang, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04771676    
Other Study ID Numbers: 2012229-11
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ascites
Pathologic Processes