Last updated on November 2018

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 recruited. If there are 3 or fewer patients without progression or death out of 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

Contact Investigators or Research Sites near you

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Chunmei Bai, Prof.

Peking Union Medical College Hospital
Beijing, China

Jianming Xu, Prof.

The 307th Hospital of Military Chinese People's Liberation Army
Beijing, China

Yuxian Bai, Prof.

Heilongjiang Cancer Hospital
Ha'erbin, China

Huichuan Sun, Prof.

Shanghai Zhongshan Hospital
Shanghai, China

Tianqiang Song, Prof.

Tianjin medical university cancer institute&hospital
Tianjin, China