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

Biliary Tract Cancer Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

• NCT number: NCT02966821
• Study type: Interventional
• Source: Hutchison Medipharma Limited
• Status: Completed
• Phase: Phase 2
• Start date: January 3, 2017
• Completion date: November 30, 2018