Status:
COMPLETED
Trial to Optimally Show the Pharmacological Action of Z-100
Lead Sponsor:
Zeria Pharmaceutical
Conditions:
Cervical Cancer
Eligibility:
FEMALE
21-79 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- FIGO stage (2008): IIIB, cervical cancer
- Pathologically confirmed squamous cell carcinoma of the cervix
- Subjects with treatment-naive cervical cancer
- Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node
- Subjects ≥21, ≤79 years of age at informed consent
- Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy
- Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy
- Eastern Cooperative Oncology Group Performance Status: 0-2
- 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
- Subjects who are willing to give informed consent
Exclusion
- Subjects who have a double cancer or are being treated for that
- Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent
- Subjects with cancer of the cervical stump which is judged by the investigator
- Subjects who have a history of being diagnosed of autoimmune disease
- Subjects who have a history of radiotherapy in the pelvis
- Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum
- Subjects complicated with a serious drug allergy
- Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid)
- Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period
- Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV)
- Subjects with symptomatic tuberculosis at the date of obtaining consent
- Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent
- Other subjects considered inappropriate to participate in the trial by the investigator
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03476018
Start Date
April 2 2018
End Date
December 10 2021
Last Update
June 16 2022
Active Locations (2)
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1
Zeria Investrigative Sites
Hanoi, Vietnam
2
Zeria Investigative sites
Ho Chi Minh City, Vietnam