Trial · NCT02082522
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
NCT02082522, Phase 3, Terminated, Concordia Laboratories Inc.; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS). Trials, record NCT02082522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02082522
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
- NCT number
- NCT02082522
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 28 participants, actual
- Lead sponsor
- Concordia Laboratories Inc.
- Conditions
- Hilar Cholangiocarcinoma
- Interventions
- Photodynamic therapy-Photofrin, Stenting procedure, Chemotherapy regimen
- First posted
- 2014-03-10
- Last updated
- 2019-08-28
- Results first posted
- 2019-08-28
- Limitations and caveats
This study was prematurely terminated due to low accrual. Consequently, there was insufficient data to allow statistical analysis. Only descriptive statistics are presented for the primary endpoint, overall survival time.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Time | Up to 26 months | Time from the date of randomization until the date of death or the last date the subject was known to be alive |
| Secondary | Time-to-bilirubin Response | Up to 30 days | From the date of randomization until the date of first documented bilirubin response |
| Secondary | Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) | Up to 26 months | From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors) |
| Secondary | Time-to-tumor Progression | Up to 26 months | From the date of first documented response until the date that tumor progression was assessed |
| Secondary | Change From Baseline on Karnofsky Performance Scale (KPS) | Baseline, 7 days | The Karnofsky Performance Scale scores range from 0% to 100%. 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 normal activity with effort and some signs or symptoms of disease. |
| Secondary | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, up to 4 weeks | The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. |
| Secondary | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 13 weeks | The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. |
| Secondary | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 16 weeks | The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. |
| Secondary | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 29 weeks | The Karnofsky Performance Scale scores range from 0% to 100%. 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 normal activity with effort and some signs or symptoms of disease. |
| Secondary | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 41 weeks | The Karnofsky Performance Scale scores range from 0% to 100%. 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 normal activity with effort and some signs or symptoms of disease. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Time | Up to 26 months | All participants randomized (intent-to-treat population) | days | MEDIAN |
| SECONDARY | Time-to-bilirubin Response | Up to 30 days | Data not collected | ||
| SECONDARY | Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) | Up to 26 months | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | percentage of participants | NUMBER |
| SECONDARY | Time-to-tumor Progression | Up to 26 months | Not collected | ||
| SECONDARY | Change From Baseline on Karnofsky Performance Scale (KPS) | Baseline, 7 days | At Day 7, all 15 subjects in the PDT +SMC group were analysed and 9/13 in the SMC Alone group were analysed. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, up to 4 weeks | At 4 weeks, 12 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 13 weeks | At 13 weeks, 8 subjects in the PDT +SMC group were analysed and 8 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 16 weeks | At 16 weeks, 9 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 29 weeks | At 29 weeks, 6 subjects in the PDT +SMC group were analysed and 5 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Baseline, 41 weeks | At 41 weeks, 2 subjects in the PDT +SMC group were analysed and 1 in the SMC Alone group was analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | score on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Time | Photodynamic Therapy-Photofrin Plus SMC | 444 | 95% Confidence Interval 111.0 to NA | days | |
| Overall Survival Time | Standard Medical Care (SMC) | 387 | 95% Confidence Interval 181.0 to NA | days | |
| Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) | Photodynamic Therapy-Photofrin Plus SMC | 56 | percentage of participants | ||
| Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) | Standard Medical Care (SMC) | 75 | percentage of participants | ||
| Change From Baseline on Karnofsky Performance Scale (KPS) | Photodynamic Therapy-Photofrin Plus SMC | -0.7 | Standard Deviation 7.99 | score on a scale | |
| Change From Baseline on Karnofsky Performance Scale (KPS) | Standard Medical Care (SMC) | 0 | Standard Deviation 0 | score on a scale | |
| Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Photodynamic Therapy-Photofrin Plus SMC | 1.7 | Standard Deviation 5.77 | score on a scale | |
| Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Standard Medical Care (SMC) | 0 | Standard Deviation 0 | score on a scale | |
| Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Photodynamic Therapy-Photofrin Plus SMC | 0.0 | Standard Deviation 7.56 | score on a scale | |
| Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) | Standard Medical Care (SMC) | 2.5 | Standard Deviation 4.63 | score on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Photodynamic Therapy-Photofrin Plus SMC | 15 | |
| Overall Study | STARTED | Standard Medical Care (SMC) | 13 | |
| Overall Study | COMPLETED | Photodynamic Therapy-Photofrin Plus SMC | 0 | |
| Overall Study | COMPLETED | Standard Medical Care (SMC) | 0 | |
| Overall Study | NOT COMPLETED | Photodynamic Therapy-Photofrin Plus SMC | 15 | |
| Overall Study | NOT COMPLETED | Standard Medical Care (SMC) | 13 |
Source ClinicalTrials.gov
Adverse events342
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Photodynamic Therapy-Photofrin Plus SMC | 9 | 15 | 9 |
| other | Nausea | Gastrointestinal disorders | Standard Medical Care (SMC) | 2 | 10 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Photodynamic Therapy-Photofrin Plus SMC | 7 | 15 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Standard Medical Care (SMC) | 5 | 10 | 5 |
| other | Constipation | Gastrointestinal disorders | Photodynamic Therapy-Photofrin Plus SMC | 7 | 15 | 7 |
| other | Constipation | Gastrointestinal disorders | Standard Medical Care (SMC) | 3 | 10 | 3 |
| other | Ascites | Gastrointestinal disorders | Photodynamic Therapy-Photofrin Plus SMC | 3 | 15 | 3 |
| other | Ascites | Gastrointestinal disorders | Standard Medical Care (SMC) | 1 | 10 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Photodynamic Therapy-Photofrin Plus SMC | 2 | 15 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Standard Medical Care (SMC) | 0 | 10 | 0 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Photodynamic Therapy-Photofrin Plus SMC | 1 | 15 |
| Total, all-cause mortality | Standard Medical Care (SMC) | 0 | 13 |
| Total, other adverse events | Photodynamic Therapy-Photofrin Plus SMC | 13 | 15 |
| Total, other adverse events | Standard Medical Care (SMC) | 10 | 10 |
| Total, serious adverse events | Photodynamic Therapy-Photofrin Plus SMC | 11 | 15 |
| Total, serious adverse events | Standard Medical Care (SMC) | 10 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Photodynamic Therapy-Photofrin Plus SMC vs Standard Medical Care (SMC): deaths from any cause | Trial comparisons |
| Photodynamic Therapy-Photofrin Plus SMC vs Standard Medical Care (SMC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02082522
GET https://conductscience.org/api/trials/v1/NCT02082522/registered?page=2