Clinical trial NCT02955771: Efficacy and Safety Study of PDT Using Deuteporfin for Unresectable Advanced Perihilar Cholangiocarcinoma
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hilar Cholangiocarcinoma
Keywords: photodynamic therapy(PDT)
stenting
Hilar Cholangiocarcinoma
Deuteporfin
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overallsurvival
timeFrame: Up to 12 months
Secondary outcomes:
measure: 1-year survival rate
timeFrame: Up to 12 months
measure: The change rate of Bile duct stricture
timeFrame: Up to 6 months
measure: The change rate of serum bilirubin
timeFrame: Up to 1 month
measure: The change rate of carbohydrate antigen 199(CA199)
timeFrame: Up to 6 months
measure: The change rate of Karnofsky Performance Scale(KPS)
timeFrame: Up to 12 months
measure: The change rate of European Organization for Research and Treatment of Cancer Quality Of Life Questionnaire C30 (EORTC QLQ-C30)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xiaoyu Yin, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: