Spots Global Cancer Trial Database for A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

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Trial Identification

Brief Title: A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

Official Title: Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study

Study ID: NCT03609489

Conditions

Biliary Carcinoma

Interventions

Capecitabine

Apatinib

Study Description

Brief Summary: 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.

Detailed Description: 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.