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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Genital Neoplasms, Female
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control (LC)	LC will be measured from the start date of injection until the date of progressive disease	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Liu Zi
• Investigators: Principal Investigator: Zi Liu, M.D, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cervical Cancer; Endometrial Cancer; H101; Ovary Cancer; Vaginal Neoplasms; Vulvar Neoplasms
• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Female
• Other Study ID Numbers: LZi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No