Clinical trial NCT03476018: Trial to Optimally Show the Pharmacological Action of Z-100
Official title: Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-03-23
Enrollment: 72
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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

Primary outcomes:
measure: Change in the number of immunological cells
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Disease-specific survival
timeFrame: 2 years
measure: Recurrence-free survival
timeFrame: 3 years
measure: Rate of adverse events/adverse drug reactions
timeFrame: 2 years
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Zeria Investrigative Sites
city: Ho Chi Minh City
country: Vietnam
facility: Zeria Investigative sites
Study officials:
References: