Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Zhongda Hospital | OTHER |
| Fudan University | OTHER |
| Xijing Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine whether transarterial chemoembolization containing arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular carcinoma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| As2O3 | Experimental | Subjects will be treated with TACE containing As2O3 |
|
| placebo | Placebo Comparator | Subjects will be treated with TACE containing placebo which mimics the arsenic trioxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE containing As2O3 | Drug | transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to progression | From date of randomization until the date of first documented progression, up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | patients proportion of CR and PR according to mRECIST | every 3 months from randomization until the date of first documented progression, up to 24 months |
| progression free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haibo Shao, MD,PHD | Contact | 862483282730 | haiboshao@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Haibo Shao, MD,PhD | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
| TACE containing placebo | Drug | transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol |
|
survival from randomization to the date of first documented progression according to the mRECIST criterion
| From date of randomization until the date of first documented progression, up to 24 months |
| overall survival | From date of randomization until the date of death from any cause, up to 60 months |
| Proportion of Participants with Adverse Events | every 3 months from randomization until the date of first documented progression, up to 24 months |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | China |
|
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
|
| Xijing Hospital,Fourth Military Medical University | Xi'an | Shaanxi | China |
|
| Zhongshan Hospital Fudan University | Shanghai | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |