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Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies

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. Identifier: NCT05051696
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : October 12, 2021
Information provided by (Responsible Party):
Liu Zi, Health Science Center of Xi'an Jiaotong University

Brief Summary:
The purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses H101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. And further research the mechanism of oncolytic viruses H101.

Condition or disease Intervention/treatment Phase
Genital Neoplasms, Female Drug: H101 Not Applicable

Detailed Description:
Patients with recurrent, radiation/chemotherapy-resistant gynecological cancer carry a poor prognosis. H101 is a recombinant human type-5 adenovirus (Ad5), in which the E1B and E3 gene have been deleted. Previous studies have shown that H101 has anticancer activity and safety in some solid tumors, but has little report in gynecological oncology. In this clinical trial, 60 recurrent or refractory gynecological cancer patients will be enrolled. Based on individual conditions, all eligible patients are intra-tumor injected oncolytic viruses H101 within 5 consecutive days combined with or without radiotherapy in sequential, three weeks for a cycle (1-4 cycles totally). Simultaneously, the tumor sample, peripheral blood, and urine specimen were collected on day1 and day5. Local control rate and side effects are recorded respectively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
Actual Study Start Date : September 26, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oncorine (H101) with or without radiotherapy
The tumor mass was injected with H101 per day for 5 consecutive days, 3 weeks as one treatment cycle, and 1 to 4 cycles according to the condition of the patient, and the patient was treated with or without radiotherapy in sequential. The injection dose of H101 was determined by the tumor volume or maximum tumor diameter:5.0×10^11 virus particles(VP) for if tumor diameter≤5cm; 1×10^12 VP for the tumor diameter between 5cm and 10cm, and 1.5×10^12 VP for the tumor diameter>10cm.
Drug: H101
Intra-tumor injected oncolytic viruses H101 within 5 consecutive days,3 weeks for a cycle (1-4cycles)
Other Name: Radiotherapy

Primary Outcome Measures :
  1. Local Control (LC) [ Time Frame: 3 months ]
    LC will be measured from the start date of injection until the date of progressive disease

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 1 year after injection ]
    ORR is the percentage of participants with presence of complete response (CR), partial response (PR). ORR assessment will be based on RECIST 1.1 criteria

  2. Progress free survival (PFS) [ Time Frame: 12 months ]
    Progress free survival is defined as the time from first day of injection until the first date of either objective disease progression or death due to any cause

  3. adverse events [ Time Frame: At day 3, 7 and 30 ]
    Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Written informed consent obtained.
  • Age ≥ 18 years at the time of study entry.
  • Histological or Cytologically diagnosed gynecological malignancies.
  • Failure to prior standard treatment (surgery, chemotherapy, radiotherapy);
  • Refractory/recurrence/metastasis gynecological cancer
  • At least one measurable lesion according to the RECIST1.1.
  • Cooperative Oncology Group-Status (ECOG Status) 0-3.
  • The last treatment should be over 2 weeks.

Exclusion Criteria:

  • History or evidence of active autoimmune disease that requires systemic treatment.
  • Participated in other anti-tumor clinical trials within 4 weeks.
  • Patients who have a contraindication to similar drugs.
  • That failure to follow up regularly.

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 identifier (NCT number): NCT05051696

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Contact: Zi Liu, M.D 86-18991232167
Contact: Qi-ying Zhang, M.D 86-18984240901

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China, Shaanxi
The First Affiliated Hospital of Xi'an Jiao Tong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: zi liu, Ph.D    +8613630223132   
Sponsors and Collaborators
Liu Zi
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Principal Investigator: Zi Liu, M.D First Affiliated Hospital Xi'an Jiaotong University
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Responsible Party: Liu Zi, Professor, Health Science Center of Xi'an Jiaotong University Identifier: NCT05051696    
Other Study ID Numbers: LZi
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Zi, Health Science Center of Xi'an Jiaotong University:
Cervical Cancer
Ovary Cancer
Endometrial Cancer
Vaginal Neoplasms
Vulvar Neoplasms
Additional relevant MeSH terms:
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Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site