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Hepatocellular CarcinomaNCT01506115

Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma

A study testing Photofrin in people with Hepatocellular Carcinoma and Obstructive Jaundice, run by Samsung Medical Center at 1 site in South Korea.

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

The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC) is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused by hemobilia and/or tumor emboli. Read more about this study

Who is it for?
Ages 19 to 70 years
What is being tested?
Photofrin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteSouth Korea
Study dates
Sep 2009to Mar 2011
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 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Known HCC: Diagnosis of HCC based on the 2005 AASLD (American Association for the Study of Liver Diseases) practice guidelines
  • Unresectable HCC: Determined based on the BCLC (Barcelona-Clinic-Liver-Cancer) staging and treatment system
  • Bile duct invasion of HCC: Confirmed by pathology via endoscopic retrograde cholangiopancreatogram (ERCP) or percutaneous transhepatic biliary drainage (PTBD). In case pathological diagnosis is clinically impossible, confirmed by dynamic CT or MRI showing that typical arterial enhancing mass in dilated bile duct and previous HCC diagnosis.

Who cannot join

  • Severe renal disease
  • Severe cardiac disease
  • Bleeding tendency
  • Porphyria

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center 81 Irwon-Ro Gangnamgu

    Seoul, 06351

Other trials in South Korea

About this study

Official title: Observational Study for Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma

The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC) is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar cholangiocarcinoma improves biliary drainage and prolongs survival. The aims of this study were to assess the safety and efficacy of PDT in unresectable HCC with bile duct invasion.

Read the detailed description

As more therapies are available for patients with hepatocellular carcinoma (HCC), the survival rate has improved. The incidence of jaundice in patients with HCC is reported as 5-44%, and substantial number of patients experience obstructive jaundice. With the improvement of survival in patients with HCC, it is not uncommon to encounter HCC patients with obstructive jaundice in clinical practice.

The prognosis of patients with obstructive jaundice caused by HCC is dismal due to progressive liver failure, rapid tumor progression and ineffective biliary drainage. The mean survival of HCC with obstructive jaundice after biliary drainage ranges from 2.5 to 4.5 months. Effective biliary drainage to improve jaundice and liver function is inevitably needed for further treatment. However, it is difficult to maintain the patency of the bile duct because recurrent obstruction frequently develops due to hemobilia.

Photodynamic therapy (PDT) with biliary drainage is a promising treatment option for advanced cholangiocarcinoma. Presence of the photosensitizer only itself is nontoxic, but showing light with specific wavelengths can induce cytotoxicity. The systemically administrated photosensitizer accumulates preferentially in proliferating tissue. If this targeted lesion is then illuminated by light of a specific wavelength, the activated photosensitizer generates reactive oxygen species, which trigger cell death by apoptosis and necrosis of the cells in the specific area. Experience with PDT in cholangiocarcinoma suggests that a survival benefit can be achieved by prolonged relief of the obstruction.

The investigators hypothesized that conducting PDT with biliary stenting in patients with obstructive jaundice caused by bile duct invasion of HCC would improves stent patency and other clinical outcomes. The aim of this study was to evaluate the safety and efficacy of PDT in HCC patients with bile duct invasion.

Being tested
Photofrin
Keywords
Hepatocellular carcinoma, Obstructive jaundice, Photodynamic therapy
Medical subject headings
Carcinoma, Hepatocellular, Jaundice, Obstructive

What participants receive

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

  • PhotofrinDrug

    Also called Photofrin (Axcan Pharma Inc., Mount-Saint-Hilaire, Canada)

    Photodynamic therapy: Intravenous Photofrin at a dose of 2 mg/kg body weight, 48 hours before photoactivation by intraluminal light illumination

Study groups in NCT01506115
Study groupRoleWhat they receive
HCC with bile duct invasionExperimentalPhotodynamic therapy with biliary drainage in patients with bile duct invasion of unresectable HCC
Receives: Drug: Photofrin

What is being measured

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

  1. Complications associated with the procedure

    • Procedure related cholangitis: fever accompanied by biliary pain that developed within three days after PDT without other infection
    • Procedure related pancreatitis: abdominal pain and increases in amylase and lipase levels threefold higher than normal
    • Procedure related bleeding: more than a 5% decrease in hematocrit compared to the initial value and coexisting bleeding on abdominal CT or endoscopy
    • Complications associated with the photosensitizer: classified as photosensitivity, burn, and pigmentation

    Measured: Six months

Secondary outcomes (3)

  1. Improvement of jaundice

    The improvement of jaundice was defined as a decrease in total bilirubin by more than 30% of the pre-procedural value.

    Measured: Six months

  2. Disappearance of hemobilia

    Disappearance of hemobilia was defined when there was no more evidence of bleeding in patients with previous hemobilia after PDT.

    Measured: Six months

  3. Survival time

    Survival time was defined as the duration from the date of imaging showing bile duct invasion of HCC to the date of death or to the last follow-up.

    Measured: Six months

Timeline

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

  1. First posted9 Jan 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506115
Sponsor's protocol ID
2009-09-048
Status last verified
Jan 2012
First submitted
29 Dec 2011
Last updated
20 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • El-Serag HB. Hepatocellular carcinoma. N Engl J Med. 2011 Sep 22;365(12):1118-27. doi: 10.1056/NEJMra1001683. No abstract available.

    PubMed 21992124

  • Singal AG, Marrero JA. Recent advances in the treatment of hepatocellular carcinoma. Curr Opin Gastroenterol. 2010 May;26(3):189-95. doi: 10.1097/MOG.0b013e3283383ca5.

    PubMed 20224395

  • Lai EC, Lau WY. Hepatocellular carcinoma presenting with obstructive jaundice. ANZ J Surg. 2006 Jul;76(7):631-6. doi: 10.1111/j.1445-2197.2006.03794.x.

    PubMed 16813631

  • Qin LX, Tang ZY. Hepatocellular carcinoma with obstructive jaundice: diagnosis, treatment and prognosis. World J Gastroenterol. 2003 Mar;9(3):385-91. doi: 10.3748/wjg.v9.i3.385.

    PubMed 12632482

  • Lau WY, Leow CK, Leung KL, Leung TW, Chan M, Yu SC. Cholangiographic features in the diagnosis and management of obstructive icteric type hepatocellular carcinoma. HPB Surg. 2000;11(5):299-306. doi: 10.1155/2000/79241.

    PubMed 10674744

  • Lau WY, Leung JW, Li AK. Management of hepatocellular carcinoma presenting as obstructive jaundice. Am J Surg. 1990 Sep;160(3):280-2. doi: 10.1016/s0002-9610(06)80023-1.

    PubMed 2168129

  • Lau W, Leung K, Leung TW, Liew CT, Chan MS, Yu SC, Li AK. A logical approach to hepatocellular carcinoma presenting with jaundice. Ann Surg. 1997 Mar;225(3):281-5. doi: 10.1097/00000658-199703000-00007.

    PubMed 9060584

  • Cho HC, Lee JK, Lee KH, Lee KT, Paik S, Choo SW, Do YS, Choo IW. Are endoscopic or percutaneous biliary drainage effective for obstructive jaundice caused by hepatocellular carcinoma? Eur J Gastroenterol Hepatol. 2011 Mar;23(3):224-31. doi: 10.1097/MEG.0b013e3283436ff6.

    PubMed 21228705

  • Matsueda K, Yamamoto H, Umeoka F, Ueki T, Matsumura T, Tezen T, Doi I. Effectiveness of endoscopic biliary drainage for unresectable hepatocellular carcinoma associated with obstructive jaundice. J Gastroenterol. 2001 Mar;36(3):173-80. doi: 10.1007/s005350170125.

    PubMed 11291880

  • Chen MF, Jan YY, Jeng LB, Hwang TL, Wang CS, Chen SC. Obstructive jaundice secondary to ruptured hepatocellular carcinoma into the common bile duct. Surgical experiences of 20 cases. Cancer. 1994 Mar 1;73(5):1335-40. doi: 10.1002/1097-0142(19940301)73:53.0.co;2-m.

    PubMed 8111698

  • Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. A comparison of lipiodol chemoembolization and conservative treatment for unresectable hepatocellular carcinoma. N Engl J Med. 1995 May 11;332(19):1256-61. doi: 10.1056/NEJM199505113321903.

    PubMed 7708069

  • Shim CS, Cheon YK, Cha SW, Bhandari S, Moon JH, Cho YD, Kim YS, Lee LS, Lee MS, Kim BS. Prospective study of the effectiveness of percutaneous transhepatic photodynamic therapy for advanced bile duct cancer and the role of intraductal ultrasonography in response assessment. Endoscopy. 2005 May;37(5):425-33. doi: 10.1055/s-2005-861294.

    PubMed 15844020

  • Zoepf T, Jakobs R, Arnold JC, Apel D, Riemann JF. Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy. Am J Gastroenterol. 2005 Nov;100(11):2426-30. doi: 10.1111/j.1572-0241.2005.00318.x.

    PubMed 16279895

  • Harewood GC, Baron TH, Rumalla A, Wang KK, Gores GJ, Stadheim LM, de Groen PC. Pilot study to assess patient outcomes following endoscopic application of photodynamic therapy for advanced cholangiocarcinoma. J Gastroenterol Hepatol. 2005 Mar;20(3):415-20. doi: 10.1111/j.1440-1746.2005.03582.x.

    PubMed 15740486

  • Dumoulin FL, Gerhardt T, Fuchs S, Scheurlen C, Neubrand M, Layer G, Sauerbruch T. Phase II study of photodynamic therapy and metal stent as palliative treatment for nonresectable hilar cholangiocarcinoma. Gastrointest Endosc. 2003 Jun;57(7):860-7. doi: 10.1016/s0016-5107(03)70021-2.

    PubMed 12776033

Questions about this trial

What is this clinical trial studying?

A study testing Photofrin in people with Hepatocellular Carcinoma and Obstructive Jaundice, run by Samsung Medical Center at 1 site in South Korea.

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 3 inclusion and 4 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 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

Complications associated with the procedure (time frame: Six 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 NCT01506115, which also lists 23 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 2015.

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