Cervical Cancer
Conditions
Brief summary
The objective of this clinical trial is to evaluate the change of the immunological parameter levels in FIGO stage IIIB cervical cancer subjects by administration of Z-100
Interventions
DRUGZ-100
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
DRUGPlacebos
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
Sponsors
Zeria Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. FIGO stage (2008): IIIB, cervical cancer 2. Pathologically confirmed squamous cell carcinoma of the cervix 3. Subjects with treatment-naive cervical cancer 4. Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node 5. Subjects ≥21, ≤79 years of age at informed consent 6. Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy 7. Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy 8. Eastern Cooperative Oncology Group Performance Status: 0-2 9. Subjects with the following organ functions; (1) WBC ≥3,000/mm3 (2) Platelet count ≥100,000/mm3 (3) Hemoglobin ≥9.5 g/dL (correction by medication, e.g. blood transfusion, iron compounds, is allowed) (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (6) Creatinine clearance: ≥50 mL/min 10. Subjects who are willing to give informed consent
Exclusion criteria
1. Subjects who have a double cancer or are being treated for that 2. Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent 3. Subjects with cancer of the cervical stump which is judged by the investigator 4. Subjects who have a history of being diagnosed of autoimmune disease 5. Subjects who have a history of radiotherapy in the pelvis 6. Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum 7. Subjects complicated with a serious drug allergy 8. Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid) 9. Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period 10. Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV) 11. Subjects with symptomatic tuberculosis at the date of obtaining consent 12. Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent 13. Other subjects considered inappropriate to participate in the trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the number of immunological cells | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
| Disease-specific survival | 2 years |
| Recurrence-free survival | 3 years |
| Rate of adverse events/adverse drug reactions | 2 years |
Countries
Vietnam
Outcome results
None listed