We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
Esophageal cancer is one of the most common malignant tumor and esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma in China. Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor. New treatments were needed. Apatinib, which was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer, is a small molecule tyrosine kinase inhibitor. It competes with intracellular VEGFR-2's ATP binding sites highly and selectively, thereby blocking downstream signaling to achieve the goal of inhibiting neovascularization in tumor tissue. We have observed in clinical practice that some patients with esophageal squamous cell carcinoma have benefited from the treatment of apatinib. So we conduct a phase II clinical trial to explore the efficacy and safety of Apatinib combined with chemotherapy (platinum and fluorouracil) in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
189
Patients will receive Apatinib at 500mg/times,oral one times daily for 28 days
the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGOne-year survival rate
The probability of survival in one year
Time frame: 12 months
Progress free survival(PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence of Treatment-Emergent Adverse Events
Safety evaluation according to the CTCAE4.0 standard, once every 1 cycle assessment
Time frame: Each follow up visit, assessed up to 12 months
Quality of life using EORTC QLQ C30 - scale
Life quality evaluation using EORTC QLQ C30 - scale,once every 1 cycle assessment
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
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