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Hilar CholangiocarcinomaPhase 2NCT02955771

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

A Phase 2 study testing PDT-Deuteporfin（6 hour), PDT-Deuteporfin（9 hour) and stenting in people with Hilar Cholangiocarcinoma, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hilar Cholangiocarcinoma
What is being tested?
PDT-Deuteporfin（6 hour), PDT-Deuteporfin（9 hour) and stenting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
4 sitesChina
Study dates
17 May 2017to 26 Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

  • Shanghai Eastern Hepatobiliary Surgery Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

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

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.

Being tested
PDT-Deuteporfin（6 hour), PDT-Deuteporfin（9 hour), stenting
Keywords
photodynamic therapy(PDT), stenting, Hilar Cholangiocarcinoma, Deuteporfin
Medical subject headings
Klatskin Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PDT-Deuteporfin（6 hour)Combination product

    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.

  • PDT-Deuteporfin（9 hour)Combination product

    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.

  • stentingDevice

    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).

Study groups in NCT02955771
Study groupRoleWhat they receive
PDT-Deuteporfin（6 hour）plus stentingExperimentalDeuteporfin (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.
Receives: Combination Product: PDT-Deuteporfin（6 hour); Device: stenting
PDT-Deuteporfin（9 hour）plus stentingExperimentalDeuteporfin (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.
Receives: Combination Product: PDT-Deuteporfin（9 hour); Device: stenting
StentingOtherEndoscopic or percutaneous stenting alone will be performed.
Receives: Device: stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overallsurvival

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

    Measured: Up to 12 months

Secondary outcomes (6)

  1. 1-year survival rate

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

    Measured: Up to 12 months

  2. The change rate of Bile duct stricture

    The date at the phase of baseline，at the end of first month, third month and sixth month

    Measured: Up to 6 months

  3. The change rate of serum bilirubin

    The date at the phase of baseline，at the first week ，at the end of first month

    Measured: Up to 1 month

  4. The change rate of carbohydrate antigen 199(CA199)

    The date at the phase of baseline，at the end of first month, third month and sixth month

    Measured: Up to 6 months

  5. The change rate of Karnofsky Performance Scale(KPS)

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

    Measured: Up to 12 months

  6. The change rate of European Organization for Research and Treatment of Cancer Quality Of Life Questionnaire C30 (EORTC QLQ-C30)

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

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2016 (estimated)
  2. Study start17 May 2017
  3. Primary completion26 Dec 2018
  4. Study completion26 Dec 2018

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955771
Sponsor's protocol ID
FDZJDTBF-NCC201512
Status last verified
Jul 2019
First submitted
2 Nov 2016
Last updated
17 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PDT-Deuteporfin（6 hour), PDT-Deuteporfin（9 hour) and stenting in people with Hilar Cholangiocarcinoma, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overallsurvival (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02955771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.

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