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the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC
HCC The is a common malignancy in the world, especially in China. Advanced HCC treatment is difficult and the prognosis is poor, which is still a great challenge and threat to the medical profession. The advent of the molecular targeted drug, Sola, has made the treatment dilemma of advanced HCC a breakthrough, but the efficacy and economic health ratio is far from satisfactory. After Sola, many new molecular targeted drugs were studied, but failed.
Although multiple treatment options, but for HCC Patient-recommended treatment programs require systematic treatment and surgery, TACE , local ablation and radiotherapy and other multidisciplinary means of combination, the selection of appropriate patients, appropriate means and timing to achieve individualized treatment.
1. Aptinib Union TACE can be generated through embolization and angiogenesis by the dual target of vascular suppression;2. TACE induces hypoxia, leading to an increase in the number of hypoxia-inducing factors that increases VEGF and PDGFR , while VEGF the and PDGFR may be important factors that induce tumor recurrence by stimulating tumor angiogenesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib combined with TACE | Experimental | patients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks |
|
| chemoemtranscatherer arterial bolization | Placebo Comparator | epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression free survival | one and a half year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | one and a half year |
| TTP | time to progression | one and a half year |
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Inclusion Criteria:
Age: 18-70 years old;
initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ;
Child-pugh liver function Rating: A level, B level;
BCLC Staging as B / C period;
before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check:
women of childbearing age must be pregnancy tests before join in the group in 7 days;
Participants volunteered to join this study should sign informed consent, with good compliance and follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Guo, MD | Contact | 18622221211 | cjr.guozhi@vip.163.com | |
| Haipeng Yu, MD | Contact | 13352070835 | jieruke@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhi Guo, MD | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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|
| Apatinib | Drug | a molecular targeted anti-tumor drugs,small molecule vascular endothelial growth factor receptor 2 inhibitor |
|
|
| DCR | disease control rate | one and a half year |
| ORR | objective response rate | one and a half year |
| QOL | number of participants with treatment-related adverse events as assessed by EORTC QLQ-C30 | one and a half year |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |