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Trial record 2 of 40 for:    "Klatskin tumor"

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

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ClinicalTrials.gov Identifier: NCT02955771
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Hilar Cholangiocarcinoma Procedure: PDT-Deuteporfin(6 hour) Procedure: PDT-Deuteporfin(9 hour) Device: stenting Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Controlled, Open-label Study of Deuteporfin Photodynamic Therapy Plus Stenting Versus Stenting Alone as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma
Study Start Date : October 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PDT-Deuteporfin(6 hour)plus stenting
Deuteporfin (7.5mg/kg) was injected intravenously 6 hours before intraluminal photoactivation (wavelength,630 nm;light dose, 180 J/cm(2)). After PDT, endoscopic or percutaneous stenting will be performed.The second treatment may be given after 3 months.
Procedure: 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.

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).

Experimental: PDT-Deuteporfin(9 hour)plus stenting
Deuteporfin (7.5mg/kg) was injected intravenously 9 hours before intraluminal photoactivation (wavelength,630 nm;light dose, 180 J/cm(2)). After PDT, endoscopic or percutaneous stenting will be performed.The second treatment may be given after 3 months.
Procedure: 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).

Stenting
Endoscopic or percutaneous stenting alone will be performed.
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged 18 or older.
  • Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage Ⅲ/Ⅳ.
  • KPS≥70.
  • Total Bilirubin<85.5 umol/L.
  • Informed consent obtained.

Exclusion Criteria:

  • The first diagnosis time of cholangiocarcinoma > 3 months before randomization.
  • Expected survival <3 months.
  • Patients with abnormal laboratory parameters: white blood cell<3.0×10(9)/L;hemoglobin <80g/L;Neutrophil Differential Count<1.5×10(9)/L;blood platelets<75×10(9)/L;or patients have other diseases of the blood system.
  • Creatinine clearance >1.5×upper limit of normal range.
  • Patients with severe liver function damage,or aspartate transaminase (AST) and/or alanine transaminase (ALT) >5×upper limit of normal range.
  • Patients have intrahepatic metastasis, or distant metastasis (including distant lymph node metastasis); or bile duct cancer patients with other parts of the primary malignant tumor.
  • Patients have activities of viral hepatitis, liver cirrhosis, liver abscess, alcoholic fatty liver, primary hepatocellular carcinoma, and other liver diseases; or patients have immunoglobulin G4 (IgG4) sclerosing cholangitis, primary sclerosing cholangitis, autoimmune cholangitis, and other cholangitis.
  • Malignancies other than cholangiocarcinoma within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer.
  • Patients had received PDT treatment prior to randomization.
  • Patients had received bile duct carcinoma resection prior to randomization.
  • Patients had received chemotherapy, or brachytherapy,or radiotherapy prior to randomization.
  • Patients had received metal stent treatment prior to randomization.
  • Presence of infection (active, untreated infection and/or acute bacterial or fungal infection) other than the infection of the bile duct (cholangitis).
  • Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) >180 mmHg and/or sitting diastolic blood pressure (DBP) >110 mmHg after medication]; have severe complications of hypertension or diabetes.
  • Presence of severe heart, lung and central nervous system diseases.
  • Presence of mental illness, or mental disorders can not accurately describe their feelings, or not according to the doctor's advice to take medication.
  • History of alcohol abuse, drug abuse in the past 1 years.
  • Presence of allergic diseases,or known to have light skin allergies or porphyria, or known to allergic to study drug(porphyrin drugs) or other similar compounds, cephalosporin antibiotics, other types penicillin, β lactamase inhibitors.
  • Patients need to use prohibited drugs in proposal during the first 2 weeks of screening, or during the trial period.
  • Patients having been enrolled in other clinical trial within 3 months prior to this clinical trial.
  • Pregnant, lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
  • The researchers weren't allowed to participate in this study as subjects.
  • Patients unsuitable for enrollment in the clinical trial according to investigators decision.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955771


Contacts
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Contact: Xiaoyu Yin, MD. PhD 020-87755766 dr_yinxy@163.com

Locations
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China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Xiaoyu Yin         
Principal Investigator: Xiaoyu Yin         
The Second Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Ping Xue         
Principal Investigator: Ping Xue         
China, Jiangsu
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Not yet recruiting
Nanjing, Jiangsu, China
Contact: Yudong Qiu         
Principal Investigator: Yudong Qiu         
China, Shanghai
Shanghai Eastern Hepatobiliary Surgery Hospital Not yet recruiting
Shanghai, Shanghai, China
Contact: Xiaoqing Jiang         
Principal Investigator: Xiaoqing Jiang         
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Xiaoyu Yin, MD. PhD First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02955771     History of Changes
Other Study ID Numbers: FDZJDTBF-NCC201512
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.:
photodynamic therapy(PDT)
stenting
Hilar Cholangiocarcinoma
Deuteporfin

Additional relevant MeSH terms:
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Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms