cervical cancer
Conditions
Interventions
administration of durvalumab, carbon-ion radiotherapy and cisplatin according to the rules of the research protocol.
Sponsors
Murata Kazutoshi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age >= 20 years and 30 kg 7. Adequate normal organ and marrow function as defined below: Haemoglobin >= 9.0 g/dL Absolute neutrophil count >= 1000 per mm3 Platelet count >= 75 x 109/L Serum bilirubin <= 1.5 x institutional upper limit of normal. 8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 9. Must have a life expectancy of at least 12 weeks. 10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Exclusion criteria
Exclusion criteria: 1) Participation in another clinical study with an investigational product during the last 3 months. 2) Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 3) Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) for other previous or concomitant tumor within 1 years prior to the first dose of study drug. 4) Any unresolved toxicity NCI CTCAE Grade >=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. a. Patients with Grade =5 years before the first dose of IP and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease 12) History of leptomeningeal carcinomatosis 13) History of active primary immunodeficiency 14) Active infection including tuberculosis (clinical evaluation that includes clinical histor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs/SAEs including DLTs | — |
Secondary
| Measure | Time frame |
|---|---|
| OS Progression free survival Distant metastasis rate at one year after treatment. Objective response Complete response rates. | — |
Contacts
Public ContactMakoto Hori
Chiba University Hospital
Outcome results
None listed