Abstract 616TiP
Background
Patients with recurrent and 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 the current evidence regarding the effect of H101 on gynecological oncology remains rare. Therefore, the purpose of this clinical trial is to evaluate the effect and safety of H101 intra-tumor injection combined with or without radiotherapy in refractory/recurrent/metastatic gynecological malignancies, and to further explore the mechanism of H101.
Trial design
In this prospective, open-label, multi-center, single-arm study, it is estimated 60 patients diagnosed with refractory/recurrent/metastatic cervical cancer, endometrial cancer, uterine sarcoma, ovarian cancer, vaginal cancer or vulvar cancer receiving standard tumor treatment will be enrolled (start date September 26, 2021). Based on individual conditions, H101 are intratumorally injected 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 are collected on day 1 and day 5. The injection dose of H101 is determined by the tumor volume or maximum tumor diameter: 5.0×1011 virus particles (vp) for tumor diameter≤5cm; 1×1012 vp for tumor diameter between 5cm and 10cm, and 1.5×1012vp for tumor diameter>10cm. The primary endpoint is local control (LC). LC will be measured from the start date of injection until the date of progressive disease. The secondary endpoints include objective response rate (ORR), progression-free survival (PFS) and adverse events (AEs). The AEs are monitored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). Study data will be collected and managed using the electronic data capture system (EDC). Patient enrollment is now ongoing and the estimated study duration are 2 years.
Clinical trial identification
The study is registered at Clinicaltrials.gov (NCT 05051696).
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.