Clinical Trial: Efficacy and Safety Study of PDT Using Deuteporfin for Unresectable Advanced Perihilar Cholangiocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multi-center, Randomized, Controlled, Open-label Study of Deuteporfin Photodynamic Therapy Plus Stenting Versus Stenting Alone as Treatment for Unresectable Advanced Perihilar Ch

Brief Summary: This is a multi-center, randomized, controlled, open-label, phase IIa clinical study.The study will observe the efficacy and safety of Deuteporfin photodynamic therapy in addition to stenting compared to stenting alone in patients with unresectable advanced Perihilar Cholangiocarcinoma.

Detailed Summary:
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.

Current Primary Outcome: Overallsurvival [ Time Frame: Up to 12 months ]

From the date of randomization until the date of death or the last date the subject was known to be alive


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 1-year survival rate [ Time Frame: Up to 12 months ]
    From the date of randomization until the date of death or the last date the subject was known to be alive
  • The change rate of Bile duct stricture [ Time Frame: Up to 6 months ]
    The date at the phase of baseline，at the end of first month, third month and sixth month
  • The change rate of serum bilirubin [ Time Frame: Up to 1 month ]
    The date at the phase of baseline，at the first week ，at the end of first month
  • The change rate of carbohydrate antigen 199(CA199) [ Time Frame: Up to 6 months ]
    The date at the phase of baseline，at the end of first month, third month and sixth month
  • The change rate of Karnofsky Performance Scale(KPS) [ Time Frame: Up to 12 months ]
    From the date of randomization until the date of death or the last date the subject was known to be alive
  • The change rate of European Organization for Research and Treatment of Cancer Quality Of Life Questionnaire C30 (EORTC QLQ-C30) [ Time Frame: Up to 12 months ]
    From the date of randomization until the date of death or the last date the subject was known to be alive


Original Secondary Outcome: Same as current

Information By: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.

Dates:
Date Received: November 2, 2016
Date Started: October 2016
Date Completion: June 2018
Last Updated: November 9, 2016
Last Verified: November 2016