Last updated on January 2017

Study of Sulfatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma


Brief description of study

A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of sulfatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma

Detailed Study Description

This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week PFS rates. In the first stage, 16 patients will be accrued. If there are 3 or fewer patients without progression or death in these 16 patients at week 16, the study will be stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable patients. Sulfatinib will be orally administered within 1 hour after breakfast once a day (QD) for every 28-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).

Clinical Study Identifier: NCT02966821

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Chunmei Bai, Prof.

Peking Union Medical College Hospital
Beijing, China
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Jianming Xu, Prof.

The 307th Hospital of Military Chinese People's Liberation Army
Beijing, China
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Yuxian Bai, Prof.

Heilongjiang Cancer Hospital
Ha'erbin, China
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Huichuan Sun, Prof.

Shanghai Zhongshan Hospital
Shanghai, China
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Tianqiang Song, Prof.

Tianjin medical university cancer institute&hospital
Tianjin, China
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