CompletedPhase 3

Trial to Optimally Show the Pharmacological Action of Z-100

Vietnam72 participantsStarted 2018-04-02

Plain-language 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

Who can participate

Age range21 Years – 79 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Change in the number of immunological cells

Timeframe: 2 years

Trial details

NCT IDNCT03476018

SponsorZeria Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-20

View on ClinicalTrials.gov More Cervical Cancer trials