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

NCT05051696 | Active Not Recruiting Phase 2

• 1 other identifier: LZi
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Neoplasms, Female

Keywords

Cervical Cancer; Ovary Cancer; Endometrial Cancer; Vaginal Neoplasms; Vulvar Neoplasms; H101

Outcome Measures

Primary Outcomes (1)

• Local Control (LC)

  LC will be measured from the start date of injection until the date of progressive disease

  3 months

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  1 year after injection

• Progress free survival (PFS)

  12 months

• adverse events

  At day 3, 7 and 30

Study Arms (1)

Oncorine (H101) with or without radiotherapy

EXPERIMENTAL

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

Interventions

H101 DRUG

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

Also known as: Radiotherapy

Oncorine (H101) with or without radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liu Zi: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Genital Neoplasms, Female; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zi Liu, M.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: September 21, 2021
• Study Start: September 26, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)