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Cholangiocarcinoma Non-resectableNCT04860154

Photodynamic Therapy for Cholangiocarcinoma

A study testing Hematoporphyrin in people with Cholangiocarcinoma Non-resectable, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cholangiocarcinoma Non-resectable
What is being tested?
Hematoporphyrin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
11 sitesChina
Study dates
17 Apr 2021to 19 Nov 2024
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ERCP cholangiocarcinoma（the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery）;

Who cannot join

  • Proximal cholangiocarcinoma (Bismuth type Ⅲ-Ⅳ, or intra-hepatic cholangiocarcinoma);
  • Patients with Karnofsky Performance Scale (KPS) score≤70；
  • Expected survival≤3months；
  • Patients with porphyria；
  • Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count(<50×10^9 / L) or using anti-coagulation drugs；
  • Bilirubin could not be reduced to less than 100mmol/L within 1 month after drainage；
Show all 19Show fewer
  • Patients have intrahepatic metastasis or distant metastasis；
  • Patients with no pathological diagnosis；
  • known to allergic to study drug(porphyrin drugs) or other similar and related compounds；
  • Other photosensitizers have been used within 4 weeks prior；
  • Metal biliary stents were placed previously；
  • Patients with contraindications to ERCP；
  • Patients with HIV infection；
  • Pregnant, parturient, or breastfeeding women；
  • Patients complicated with other malignant tumors；
  • Patients with severe liver function damage；
  • Patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate PDT；
  • Patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects；
  • Patients with other contraindications for photodynamic therapy.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Southwest Hospital, Army Medical University

    Chongqing, Chongqing Municipality, 400038

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Shandong Provincial Third Hospital

    Jinan, Shandong, 250000

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • General Hospital of Taiyuan Iron and Steel Corporation

    Taiyuan, Shanxi, 030008

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • The first affiliated hospital of Xi 'an JiaoTong university

    Xi'an, Shaanxi, 710061

  • General Hospital of Ningxia Medical University

    Yingchuan, Ningxia, 750004

Other trials in China

About this study

Official title: Evaluation of Bile Duct Patency After Photodynamic Therapy in Unresectable Cholangiocarcinoma：a Prospective Non-randomized Controlled Study

Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.

Read the detailed description

Cholangiocarcinoma is a malignant tumor originating from the bile duct epithelium, accounting for about 70% of the malignant tumors of the bile duct system. Patients have no obvious clinical symptoms in the early stage. After late diagnosis, the effective treatment is surgical resection and \& or liver transplantation, and chemotherapy is only used as adjuvant or palliative treatment. Some types of cholangiocarcinomas, such as hilar cholangiocarcinomas, are difficult to achieve radical resection due to their anatomical location, early invasions and are prone to recurrence with a poor long-term efficacy after surgery. Therefore, the comprehensive treatment of cholangiocarcinoma by multiple means urgently needs to be explored. In recent years, photodynamic therapy (PDT), as a new local treatment method, has attracted increasing attention.

This study investigates the bile duct patency and effectiveness of photodynamic therapy compare with ordinary ERCP treatment for cholangiocarcinoma including the median survival, overall survival, and other indicators of side effects.

Being tested
Hematoporphyrin
Keywords
ERCP, PDT, Cholangiocarcinoma, Bile duct drainage, Stent
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • HematoporphyrinDrug

    Also called ERCP stents

    Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or bald metal stents will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.

Study groups in NCT04860154
Study groupRoleWhat they receive
PDT with stentExperimentalBefore photodynamic therapy, candidate patients undergoing biliary biopsy and biliary duct drainage. If pathology shows a bile duct malignancy, PDT therapy will carry out until total bilirubin drops below 100 μmol/L.Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or metal stent will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.
Receives: Drug: Hematoporphyrin
ERCP stentNo interventionAfter obtaining bile duct biopsy, the candidates were placed with biliary plastic stents or metal stents directly.

What is being measured

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

  1. Bile duct patency

    Patency period of the stents after treatment

    Measured: 3years (every 3 months or obstruction appears)

  2. Median survival time

    The time of the half of the patients survived after initial therapy

    Measured: 3years (every 3 months）

Secondary outcomes (6)

  1. Overall survival

    The time from initial therapy to death or the end of the study

    Measured: 5years (every 3 months）

  2. Karnofsky Performance Scale

    The Karnofsky Performance Scale scores range from 0 (death) to 100 (normal). The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is a normal activity with effort and some signs or symptoms of the disease. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation

    Measured: 1year (baseline and every 3 months）

  3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30

    EORTCQLQ-C30 score used to assess the quality of life of cancer patients. EORTCQLQ-C30 score contains 30 questions, the first 28 questions include 1-4 points, the lower the score, the better; but the latter two questions include 1-7 points, the higher the score, the better. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation

    Measured: 1year (baseline and every 3 months）

  4. The change of weight in kilograms

    Weight changes of the patient before and after PDT treatment, pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation

    Measured: 1year (baseline and every 3 months）

  5. Beck Anxiety Inventory

    BAI is a 21-item self-reported questionnaire that measures the existence and severity of symptoms of anxiety. Each of the 21 items on the BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe", pre-operation, 1 month, 3 months, 6 months, 9 months and 12 months after the operation

    Measured: 1year (baseline and every 3 months）

  6. Cumulative treatment costs

    The overall treatment costs from initial PDT to death or the end of the study

    Measured: 5years (baseline and in each year）

Timeline

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

  1. First posted26 Apr 2021
  2. Study start17 Apr 2021
  3. Primary completion19 Nov 2024
  4. Study completion19 Nov 2024

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860154
Sponsor's protocol ID
Photodynamic therapy
Status last verified
Nov 2024
First submitted
17 Apr 2021
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu Y, Liu L, Wu JC, Bie LK, Gong B. Efficacy and safety of photodynamic therapy for unresectable cholangiocarcinoma: A meta-analysis. Clin Res Hepatol Gastroenterol. 2015 Dec;39(6):718-24. doi: 10.1016/j.clinre.2014.10.015. Epub 2015 Jun 10.

    PubMed 26070572

  • Gonzalez-Carmona MA, Bolch M, Jansen C, Vogt A, Sampels M, Mohr RU, van Beekum K, Mahn R, Praktiknjo M, Nattermann J, Trebicka J, Branchi V, Matthaei H, Manekeller S, Kalff JC, Strassburg CP, Weismuller TJ. Combined photodynamic therapy with systemic chemotherapy for unresectable cholangiocarcinoma. Aliment Pharmacol Ther. 2019 Feb;49(4):437-447. doi: 10.1111/apt.15050. Epub 2019 Jan 13.

    PubMed 30637783

  • Strand DS, Cosgrove ND, Patrie JT, Cox DG, Bauer TW, Adams RB, Mann JA, Sauer BG, Shami VM, Wang AY. ERCP-directed radiofrequency ablation and photodynamic therapy are associated with comparable survival in the treatment of unresectable cholangiocarcinoma. Gastrointest Endosc. 2014 Nov;80(5):794-804. doi: 10.1016/j.gie.2014.02.1030. Epub 2014 May 15.

    PubMed 24836747

  • Talreja JP, Degaetani M, Ellen K, Schmitt T, Gaidhane M, Kahaleh M. Photodynamic therapy in unresectable cholangiocarcinoma: not for the uncommitted. Clin Endosc. 2013 Jul;46(4):390-4. doi: 10.5946/ce.2013.46.4.390. Epub 2013 Jul 31.

    PubMed 23964337

Questions about this trial

What is this clinical trial studying?

A study testing Hematoporphyrin in people with Cholangiocarcinoma Non-resectable, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 11 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 1 inclusion and 19 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Bile duct patency (time frame: 3years (every 3 months or obstruction appears)). The study lists 2 primary outcomes in all. 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 NCT04860154, which also lists 4 linked publications.

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 20 Nov 2024.

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