Genital Neoplasms, Female
Conditions
Keywords
Cervical Cancer, Ovary Cancer, Endometrial Cancer, Vaginal Neoplasms, Vulvar Neoplasms, H101
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.
Interventions
DRUGH101
Intra-tumor injected oncolytic viruses H101 within 5 consecutive days,3 weeks for a cycle (1-4cycles)
Sponsors
Liu Zi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Control (LC) | 3 months | LC will be measured from the start date of injection until the date of progressive disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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 |
| Progress free survival (PFS) | 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 |
| adverse events | 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 |
Countries
China
Outcome results
None listed