A Phase 2 interventional study of Apatinib in Carcinoma, Hepatocellular, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-25.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
In this phase 2 study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for hepatocellular carcinoma with portal vein tumor thrombus.
Portal vein tumor thrombus (PVTT) is one of the characteristics of advanced stage for patients with hepatocellular carcinoma (HCC). There's limited treatment choice for these patients. Even for those who underwent curative resection (R0 resection), the recurrence rate was extremely high. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently, which had been proven effective in many solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor. Phase 2 study of apatinib for patients with advanced HCC had shown signals of clinical efficacy and modest safety. In this study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for HCC with PVTT.
Main organs function is normal including:
blood routine examination
biochemical test
Exclusion Criteria:
Apatinib mesylate tablets 500 mg po qd.
Drug: Apatinib
Apatinib mesylate tablets 500 mg po qd.
recurrence-free survival
From the date of liver surgery to the date of diagnosis of tumor recurrence
Time frame: 24 months
overall survival
From the date of liver surgery to the date of death
Time frame: 24 months
safety: the potential side effects
The potential side effects
Time frame: 24 months
Plan to share: No
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital