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Spots Global Cancer Trial Database for Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma

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We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

Surufatinib

Study Description

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jianming Xu, Prof.

Affiliation: The 307th Hospital of Military Chinese People's Liberation Army

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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