Back to resultsIntra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
Primary Purpose
Genital Neoplasms, Female
Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
H101
Sponsored by
About this trial
This is an interventional treatment trial for Genital Neoplasms, Female focused on measuring Cervical Cancer, Ovary Cancer, Endometrial Cancer, Vaginal Neoplasms, Vulvar Neoplasms, H101
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Xi'an Jiao Tong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncorine (H101) with or without radiotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Local Control (LC)
LC will be measured from the start date of injection until the date of progressive disease
Secondary Outcome Measures
Objective Response Rate (ORR)
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
Progress free survival (PFS)
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
adverse events
Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05051696
Brief Title
Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
Official Title
Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 26, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liu Zi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Neoplasms, Female
Keywords
Cervical Cancer, Ovary Cancer, Endometrial Cancer, Vaginal Neoplasms, Vulvar Neoplasms, H101
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oncorine (H101) with or without radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
H101
Other Intervention Name(s)
Radiotherapy
Intervention Description
Intra-tumor injected oncolytic viruses H101 within 5 consecutive days,3 weeks for a cycle (1-4cycles)
Primary Outcome Measure Information:
Title
Local Control (LC)
Description
LC will be measured from the start date of injection until the date of progressive disease
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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
Time Frame
1 year after injection
Title
Progress free survival (PFS)
Description
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
Time Frame
12 months
Title
adverse events
Description
Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Time Frame
At day 3, 7 and 30
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zi Liu, M.D
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiao Tong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
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