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The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | use dexamethasone 10mg (2ml) I.A. during TACE |
|
| control group | Placebo Comparator | use normal saline 2ml I.A. during TACE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | use dexamethasone 10mg (2ml) I.A. during TACE |
| |
| Measure | Description | Time Frame |
|---|---|---|
| response rate (RR) | 1 month after TACE | |
| proportions of participants with severe adverse events according to CTCAE v4.03 | 1 month after TACE |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | From date of randomization until the date of death from any cause, assessed up to 60 months | |
| progression-free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaohua Li, MD | Contact | +8615088064187 | lishaoh@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | +86-20 | China |
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| Normal Saline |
| Drug |
use normal saline 2ml I.A. during TACE |
|
| time to progression (TTP) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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