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

NCT02955771 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-07-17

No results posted yet for this study

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.

Conditions

  • Hilar Cholangiocarcinoma

Interventions

COMBINATION_PRODUCT

PDT-Deuteporfin（6 hour)

Photodynamic therapy (PDT) involves the i.v. injection of Deuteporfin (7.5 mg/kg，Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd，Shanghai，China） followed by the illumination of the tumor. 6 hours after the injection,a laser light ( (wavelength,630 nm; light dose, 180 J/cm(2)；Guilin Xingda Photoelectric Medical Calinstrument Co., Ltd，,Fujian, China） will be applied to the tumor.The second courses of PDT may be given at 3-month intervals.

COMBINATION_PRODUCT

PDT-Deuteporfin（9 hour)

Photodynamic therapy (PDT) involves the i.v. injection of Deuteporfin (7.5 mg/kg，Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd，Shanghai，China) followed by the illumination of the tumor.9 hours after the injection,a laser light ( (wavelength,630 nm; light dose, 180 J/cm(2)；Guilin Xingda Photoelectric Medical Calinstrument Co., Ltd，,Fujian, China) will be applied to the tumor. The second courses of PDT may be given at 3-month intervals.

DEVICE

stenting

The stenting procedure consists in the placement of plastic stents （Boston Scientific Corporation, MA,USA；or Cook Medical, Bloomington,USA）above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC).

Sponsors & Collaborators

  • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoyu Yin, MD. PhD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2018-12-26
Completion
2018-12-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955771 on ClinicalTrials.gov