Clinical trial

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

Name

LZi

Description

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.

Trial arms

Trial start

2021-09-26

Estimated PCD

2024-03-30

Trial end

2025-03-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

H101

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

Arms:

Oncorine (H101) with or without radiotherapy

Other names:

Radiotherapy

Size

120

Primary endpoint

Local Control (LC)

3 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

Updated at

2024-06-04

1 organization

1 drug

1 abstract

2 indications

Organization

Drug

Indication

Indication

Abstract

The efficacy of recombinant human adenovirus type 5 (H101) intra-tumor therapy in persistent/recurrent/metastatic gynecological cancer and the exploration of changes in tumor microenvironment.

Org: The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China,