Clinical trial NCT05051696: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Genital Neoplasms, Female
Keywords: Cervical Cancer
Ovary Cancer
Endometrial Cancer
Vaginal Neoplasms
Vulvar Neoplasms
H101
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Local Control (LC)
timeFrame: 3 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 1 year after injection
measure: Progress free survival (PFS)
timeFrame: 12 months
measure: adverse events
timeFrame: At day 3, 7 and 30
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zi Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References: