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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 0.2 microgram Z-100 | Experimental |
| |
| 2 microgram Z-100 | Experimental |
| |
| 20 microgram Z-100 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-100 | Drug | Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of immunological cells | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years | |
| Disease-specific survival | 2 years | |
| Recurrence-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeria Investrigative Sites | Hanoi | Vietnam | ||||
| Zeria Investigative sites |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C031208 | specific substance maruyama |
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| Placebos | Drug | Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days |
|
| 3 years |
| Rate of adverse events/adverse drug reactions | 2 years |
| Ho Chi Minh City |
| Vietnam |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |