Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group TACE | Active Comparator | TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated |
|
| Group Combination | Experimental | All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| FACT-Hep | FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks | six months |
| Disease control rate | CR+PR+SD |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinlong Song, MD | Contact | +8653167626411 | songjlmd@gmail.com | |
| Wenbo Shao, MD,Ph D | Contact | +8653167626412 | shaowenbomd@gmai.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinlong Song, MD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Medical Imaging Research Institute | Jinan | Shandong | 250021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| sorafenib combined with TACE | Drug | All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study |
|
| six months after TACE |
| Safety | Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) | six months |
| PFS and OS | The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively | two years |
| Number of TACE sessions and the interval time between two TACE sessions | 2 years |
| AFP | six months |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250114 | China |
|
| Shandong Cancer Hospital and Institute | Jinan | Shandong | 250117 | China |
| the Affiliated Hospital of Medical College Qingdao University | Qingdao | Shandong | 266003 | China |
|
| Yantai Yuhuangding Hospital | Yantai | Shandong | 264000 | China |
|
| 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 |
Not provided
Not provided