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The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC.
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of our previous clinical studies, we intends to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib | Experimental | a molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | one year | |
| Progression free survival (PFS) | one year | |
| Overall survival (OS) |
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Inclusion Criteria:
Before doing any research steps, the patient's informed consent must be obtained first.
The diagnosis of HCC: histologic diagnosis or Alpha fetoprotein (AFP) with two kinds of imaging diagnosis.
Patients of Barcelona stage(BCLC) C with first-line treatment failure or non tolerance to sorafenib.
Ages of 18 to 75 years old.
Child-Pugh score between 5-7 points, patients of Child-Pugh 7 points should be without ascites.
Eastern Cooperative Oncology Group performance score (ECOG PS) is 0-1 point.
Adequate organ function meeting the following:
Hemoglobin(HBG)≧9.0g/dl Neutrophil count(ANC) ≧1,500/mm3 Platelet count(PLT)≧50,000/ul Total bilirubin (TBIL)< 2mg/dL (3mg/dL, Child-Pugh B) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 5×ULN (upper limit of normal) ALP (alkaline phosphatase ) < 4×ULN PT (prothrombin time) >50% or PT-INR<2.3, <6 seconds or greater than that of the control
For patients taking warfarin, at least once a week to a close monitoring of the patients, until, according to the standard of treatment, at every time of medication, the subjects' INR measurements has been stable
SCr (serum creatinine) <1.5×ULN
For pregnant women, the results of serum pregnancy tests must be negative within 14 days before initiation of treatment.
All men and women who participated in the study had to take reliable contraceptive measures within the trial and two weeks of after the trial.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ti Zhang, MD | Contact | 13920350428 | zhangti@tjmuch.com | |
| Hui-Kai Li, MD | Contact | 13820377269 | tjchlhk@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ti Zhang | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33145266 | Derived | Hou Z, Zhu K, Yang X, Chen P, Zhang W, Cui Y, Zhu X, Song T, Li Q, Li H, Zhang T. Apatinib as first-line treatment in patients with advanced hepatocellular carcinoma: a phase II clinical trial. Ann Transl Med. 2020 Sep;8(17):1047. doi: 10.21037/atm-20-2990. |
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the plan to share IPD is under consideration.
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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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| one year |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[Quality of life] | one year |
| Incidence of Treatment-Emergent Adverse Events [Safety] | one year |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |