Biliary Carcinoma Clinical Trial
Official title:
Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study
It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.
Subjects were randomly divided into experimental and control groups. The experimental group
was postoperatively treated with apatinib combined with capecitabine for adjuvant therapy of
biliary cancer, and the control group was treated with capecitabine alone.
Progression free survival (PFS), overall survival (OS), time to progression (TTP), objective
response rate (ORR), disease control rate (DCR), EORTC QLQ-C30, HCC-18 and drug safety: vital
signs, laboratory indicators, adverse event (AE), and serious adverse event (SAE),
drug-related AE and SAE and their specific AE (such as hypertension, proteinuria, and
hand-foot syndrome) were followed for research in the two groups to evaluate the efficacy and
safety of the two regimens for the treatment of biliary tract cancer according to the
standard of NCI-CTCAE V4.0.
A rigorous, randomized and prospective study was conducted to compare the efficacy and safety
in treating biliary cancer between the combined use of apatinib mesylate plus capecitabine
and capecitabine alone, with a view to improving the survival outcome and life quality of
patients with biliary tract cancer.
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|---|---|---|---|
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N/A |