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Brief Title: Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
Official Title: A Phase II, Single-arm, Open-label, Multicenter Study to Assess the Efficacy and Safety of Surufatinib as a Second-line Treatment in Patients With Surgically Unresectable or Metastatic Biliary Tract Carcinoma
Study ID: NCT02966821
Brief Summary: A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma
Detailed 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. Surufatinib 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Peking Union Medical College Hospital, Beijing, Beijing, China
The 307th Hospital of Military Chinese People's Liberation Army, Beijing, Beijing, China
Heilongjiang Cancer Hospital, Ha'erbin, Heilongjiang, China
Shanghai Zhongshan Hospital, Shanghai, Shanghai, China
Tianjin medical university cancer institute&hospital, Tianjin, Tianjin, China
Name: Jianming Xu, Prof.
Affiliation: The 307th Hospital of Military Chinese People's Liberation Army
Role: PRINCIPAL_INVESTIGATOR