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

Genital Neoplasms, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05051696
• Other study ID #: LZi
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 26, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2024
• Source: Health Science Center of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Neoplasms

Intervention

Drug:
• H101
Intra-tumor injected oncolytic viruses H101 within 5 consecutive days,3 weeks for a cycle (1-4cycles)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Liu Zi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control (LC)	LC will be measured from the start date of injection until the date of progressive disease	3 months
Secondary	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	1 year after injection
Secondary	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	12 months
Secondary	adverse events	Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0	At day 3, 7 and 30