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

Liu Zi

Status and phase: Active, not recruiting; Phase 2

Conditions: Genital Neoplasms, Female

Treatments: Drug: H101

Study type: Interventional

Funder types: Other

Identifiers

NCT05051696

LZi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Oncorine (H101) with or without radiotherapy

Experimental group

Description:

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.

Treatment:

Drug: H101