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

Phase 2

Active, not recruiting

• Conditions: Genital Neoplasms, Female
• Interventions: Drug: H101

• Registration Number: NCT05051696
• Lead Sponsor: Liu Zi

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.

Study Timeline

• Study First Submitted: 2021-09-11
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-21
• Study Start: 2021-09-26
• Primary Completion: 2024-03-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncorine (H101) with or without radiotherapy	H101	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.

Primary Outcome Measures

Name	Time	Method
Local Control (LC)	3 months	LC will be measured from the start date of injection until the date of progressive disease

Secondary Outcome Measures

Name	Time	Method
Progress free survival (PFS)	12 months	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
Objective Response Rate (ORR)	1 year after injection	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
adverse events	At day 3, 7 and 30	Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China