Carcinoma, HepatocellularPhase 3NCT00355355
A Phase 3 Study of Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)
A Phase 3 study testing Talaporfin sodium, Interstitial Light Emitting Diodes and Percutaneous placement of device in the liver in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by Light Sciences Oncology at 34 sites in 11 countries.
Trial summary
The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Liver Neoplasms
- What is being tested?
- Talaporfin sodium, Interstitial Light Emitting Diodes and Percutaneous placement of device in the liver
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 34 sitesin 11 countries
- Study dates
- Jul 2006to Sep 2012
- Phase
- Phase 3
- 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
- A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: A. Two different imaging techniques with characteristics that suggest HCC; B. Combination of one imaging technique that suggests HCC and serum AFP level >400 ng/mL; C. Histological evidence of HCC
- ECOG Performance Status 0-2
- Life expectancy of at least 16 weeks
- Patients may have received previous antineoplastic therapy; at least 3 weeks must have elapsed since the completion of any prior therapy and the patient must have recovered from acute side effects.
- Understanding and ability to sign written informed consent
- 18 years of age or more
- Adequate hematologic, liver and renal functions as evidenced by the following: WBC >= 2,400/mm³ ; Platelet Count >= 75,000/µl ; Hemoglobin >= 9.4 gm/dL ; PT and PTT <= 1.5 Control ; SGOT, SGPT <= 5 × ULN ; Bilirubin <= 2.5 × ULN ; Alk Phos <= 3 × ULN ; Creatinine <= 2.5 mg/dL (SI: 221 mmol/L) ; Albumin >= 2 g/dL
Who cannot join
- Patients who are candidates for surgery with curative intent are not eligible
- Patients with 6 or more lesions are not eligible
- Patients with greater than 50% of parenchyma disease involvement are excluded
- Patients with Child-Pugh C cirrhosis are excluded
- Patients with diffuse HCC are excluded
- Patients with grade 3 ascites are excluded
Show all 11Show fewer
- Evidence of major vessel invasion or extrahepatic disease is excluded. Lymph node involvement in the hilum region of the liver is eligible if the nodes do not exceed 2 cm.
- Known sensitivity to porphyrin-type drugs or known history of porphyria are exclusionary
- Pregnancy or breast-feeding patients are excluded. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study
- Concurrent participation in another clinical trial involving experimental treatment is excluded
- Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data are excluded.
Trial locations and contacts
34 sites in 11 countries.
34 sites in 11 countries
Philippines6 sites
Cebu Doctors University Hospital
Cebu City
Vicente Sotto Memorial Medical Center
Cebu City
Santo Tomas University Hospital
Manila
The Medical City
Pasig
National Kidney and Transplant Institute
Quezon City
St. Luke's Medical Center
Quezon City
South Korea6 sites
Pusan National University Hospital
Busan
Seoul National University Bundang Hospital
Gyeonggi-do
Korea University Medical Center Anam Hospital
Seoul
Kyunghee Univeristy Medical Center
Seoul
Samsung Medical Center
Seoul
Sinchon Severance Hospital, Yonsei University
Seoul
India5 sites
Dr. Kamakshi Memorial Hospital
Chennai
SMS Medical College
Jaipur
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow
Cancer Clinic
Nagpur, 440012
Shatabdi Super Specialty Hospital
Nashik
Malaysia4 sites
Island Hospital
George Town
Lam Wah Ee Hospital
George Town
Hospital Universiti Kebangsaan Malaysia
Kuala Lumpur
University Malaya Medical Centre
Kuala Lumpur
Serbia3 sites
Clinical Center of Serbia, Institute for Gastroenterology and Hepatology
Belgrade
Clinical Center of Serbia
Belgrade
Military Medical Academy
Belgrade
Hong Kong2 sites
Prince of Wales Hospital, Dept. of Clincal Oncology
New Territories
Tuen Mun Hospital
Tuenmen, New Territories
Poland2 sites
Szpital Uniwersytecki CMUJ
Krakow
Centralny Szpital Kliniczny MSWiA
Warsaw
Singapore2 sites
Singapore General Hospital
Singapore, 169608
National Cancer Centre
Singapore, 169610
Thailand2 sites
Mahidol University, Siriraj Hospital
Bangkok
Chiang Mai University
Chiang Mai
About this study
Official title: A Phase 3 Randomized Study to Evaluate Survival of Patients Treated With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy.
Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body.
Read the detailed description
Patients who provide Informed Consent and satisfy the Eligibility Criteria will be placed in an eligibility pool for randomization for either the Litx™ treatment arm or the standard of care arm.
A Patient assigned to the Litx™ treatment group may receive up to three Litx™ treatments. Regardless of which group the patient is assigned the treatment planning should anticipate ablation of all lesions with three Litx™ treatments using up to 4 Light Sources per treatment (a single Light Source may kill 2 cm x 4 cm of tissue).
The Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions. Following imaging confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 1 mg/kg. Fifteen minutes to one hour following completion of LS11 administration, delivery of 200 J/cm per Light Source at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for any complication after Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and maintained for up to two weeks.
Patients designated for the standard of care group, will receive current standard of care treatment recommended by the investigating physician. Should the elected treatment fail, a patient may switch to another standard of care treatment.
A patient designated for the Litx™ treatment group may receive up to two additional Litx™ treatments. A second and third treatment with Litx™ may be considered if any residual tumor or new tumor exists. The third treatment must take place within six months after the first treatment. A patient may switch to receiving standard of care after the third Litx™ treatment or as recommended by the investigator as necessary.
For either the Litx™ group or standard of care group once all treatment therapies have been exhausted the patient will be followed for survival. No protocol-directed office visits are required during this period and the patient may be followed by phone and/or e-mail at four week intervals. All patients will be monitored for survival from the time of randomization to the time of death from any cause or until at least 142 deaths have been observed, whichever occurs first.
- Conditions
- Carcinoma, Hepatocellular, Liver Neoplasms
- Being tested
- Talaporfin sodium, Interstitial Light Emitting Diodes, Percutaneous placement of device in the liver, Standard Care
- Keywords
- Hepatocellular carcinoma, HCC, Liver Neoplasms, Talaporfin Sodium (LS11), Light emitting diodes (LEDs), Light activation
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talaporfin sodiumDrug
LS11 (Talaporfin Sodium) slowly administered (3-5 min.) in a free flowing intravenous drip at a dose of 1 mg/kg.
Interstitial Light Emitting DiodesDevice
200 J/cm per Light Source at 20 mW/cm light energy
Percutaneous placement of device in the liverProcedure or surgery
Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions.
Standard CareProcedure or surgery
The standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution.
| Study group | Role | What they receive |
|---|---|---|
| Litx | Experimental | Drug: Talaporfin Sodium (1 mg/kg iv), Device: Interstitial Light Emitting Diodes (200 J/cm) 3 treatments within 6 months Receives: Drug: Talaporfin sodium; Device: Interstitial Light Emitting Diodes; Procedure: Percutaneous placement of device in the liver |
| Standard Care | Active comparator | The standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution. Receives: Procedure: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 130 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Light Sciences Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sy-Shi Wang, PhD, Study director, Light Sciences Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355355
- Sponsor's protocol ID
- LSO-OL005
- Status last verified
- Jan 2015
- First submitted
- 19 Jul 2006
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Study to Evaluate Survival of Patients Treated With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00355355
- Acronym / sponsor ID
- LSO-OL005
- Conditions
- Carcinoma, Hepatocellular, Liver Neoplasms
- Keywords
- Hepatocellular carcinoma, HCC, Liver Neoplasms, Talaporfin Sodium (LS11), Light emitting diodes (LEDs), Light activation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Light Sciences OncologyIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy.
Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body.
Detailed description
Patients who provide Informed Consent and satisfy the Eligibility Criteria will be placed in an eligibility pool for randomization for either the Litx™ treatment arm or the standard of care arm.
A Patient assigned to the Litx™ treatment group may receive up to three Litx™ treatments. Regardless of which group the patient is assigned the treatment planning should anticipate ablation of all lesions with three Litx™ treatments using up to 4 Light Sources per treatment (a single Light Source may kill 2 cm x 4 cm of tissue).
The Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions. Following imaging confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 1 mg/kg. Fifteen minutes to one hour following completion of LS11 administration, delivery of 200 J/cm per Light Source at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for any complication after Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and maintained for up to two weeks.
Patients designated for the standard of care group, will receive current standard of care treatment recommended by the investigating physician. Should the elected treatment fail, a patient may switch to another standard of care treatment.
A patient designated for the Litx™ treatment group may receive up to two additional Litx™ treatments. A second and third treatment with Litx™ may be considered if any residual tumor or new tumor exists. The third treatment must take place within six months after the first treatment. A patient may switch to receiving standard of care after the third Litx™ treatment or as recommended by the investigator as necessary.
For either the Litx™ group or standard of care group once all treatment therapies have been exhausted the patient will be followed for survival. No protocol-directed office visits are required during this period and the patient may be followed by phone and/or e-mail at four week intervals. All patients will be monitored for survival from the time of randomization to the time of death from any cause or until at least 142 deaths have been observed, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Litx | Experimental | Drug: Talaporfin sodium, Device: Interstitial Light Emitting Diodes, Procedure: Percutaneous placement of device in the liverDrug: Talaporfin Sodium (1 mg/kg iv), Device: Interstitial Light Emitting Diodes (200 J/cm) 3 treatments within 6 months |
| Standard Care | Active comparator | Procedure: Standard CareThe standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: A. Two different imaging techniques with characteristics that suggest HCC; B. Combination of one imaging technique that suggests HCC and serum AFP level >400 ng/mL; C. Histological evidence of HCC
- ECOG Performance Status 0-2
- Life expectancy of at least 16 weeks
- Patients may have received previous antineoplastic therapy; at least 3 weeks must have elapsed since the completion of any prior therapy and the patient must have recovered from acute side effects.
- Understanding and ability to sign written informed consent
Key exclusion criteria (11 listed)
- Patients who are candidates for surgery with curative intent are not eligible
- Patients with 6 or more lesions are not eligible
- Patients with greater than 50% of parenchyma disease involvement are excluded
- Patients with Child-Pugh C cirrhosis are excluded
- Patients with diffuse HCC are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talaporfin sodiumLS11 (Talaporfin Sodium) slowly administered (3-5 min.) in a free flowing intravenous drip at a dose of 1 mg/kg. | Drug | Litx |
| Interstitial Light Emitting Diodes200 J/cm per Light Source at 20 mW/cm light energy | Device | Litx |
| Percutaneous placement of device in the liverLitx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions. | Procedure or surgery | Litx |
| Standard CareThe standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution. | Procedure or surgery | Standard Care |
Primary outcome
Overall survival
Time frame: 130 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sy-Shi Wang, PhD study director
Light Sciences Oncology
34 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Talaporfin sodium, Interstitial Light Emitting Diodes and Percutaneous placement of device in the liver in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by Light Sciences Oncology at 34 sites in 11 countries.
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 7 inclusion and 11 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Philippines, South Korea, India, Malaysia, Serbia and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Overall survival (time frame: 130 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2015.