Trial · NCT02807181
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
NCT02807181, Phase 2, Phase 3, Terminated, Sirtex Medical; results first posted 2025-05-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma. Trials, record NCT02807181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02807181
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
- NCT number
- NCT02807181
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 89 participants, actual
- Lead sponsor
- Sirtex Medical
- Conditions
- Intrahepatic Cholangiocarcinoma
- Interventions
- Cisplatin-gemcitabine, Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
- First posted
- 2016-06-21
- Last updated
- 2025-05-09
- Results first posted
- 2025-05-09
- Limitations and caveats
SIRCCA enrollment from February 2017 (180 planned) was slow and thus enrollment terminated early in October 2019 (89 treated). Follow-up until 29 April 2021 was to ensure ≥18 months of data although the primary endpoint was underpowered. An audit to the clinical database detected issues leading to a low level of confidence in the trustworthiness of the collected data. Pharmacovigilance case reconciliation was thus also confounded. The results posted cannot be relied upon as accurate.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival at 18 Months | 18 months following the date of randomization. | Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization. The outcome was analyzed but the clinical database is not deemed to be reliable. |
| Secondary | Liver-specific Progression Free Survival (PFS) | From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months.. | Liver-specific PFS was defined as the number of days between randomization and the date of first tumor progression in the liver. Diagnosis of tumor progression was to be made using RECIST 1.1. |
| Secondary | Progression Free Survival (PFS) at Any Site | From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months. | PFS was defined as the time interval between randomization and the date of tumor progression. Diagnosis of tumor progression was to be made using RECIST 1.1. The outcome was not analyzed due to unreliability of the clinical database. |
| Secondary | Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver | From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months. | The outcome was not analyzed due to unreliability of the clinical database. |
| Secondary | Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site | From the date of first treatment until progression at any site, assessed up to 36 months. | The outcome was not analyzed due to unreliability of the clinical database. |
| Secondary | Overall Survival | From date of randomization until the date of death from any cause, assessed up to 36 months. | The outcome was not analyzed due to unreliability of the clinical database. |
| Secondary | Liver Surgical Resection and Ablation Rate | 18 months following the date of randomization. | To assess the number of patients in each arm who are downstaged by protocol therapy and can proceed to liver resection or ablation. The specific assessments will be the classification of resection as R0, R1 or R2, the presence of viable tumor or fibrosis, and the nearest resection margin. The outcome was not analyzed due to unreliability of the clinical database. |
| Secondary | Incidence of Adverse Events (Safety and Tolerability) | Informed consent until 28 days post last dose of protocol chemotherapy. | Adverse events (AEs) as assessed by CTCAE v. 4.0. Summaries of non-serious AEs (clinical database, MedDRA 20.1) and serious adverse events (SAEs; pharmacovigilance database, MedDRA 25.1) are provided for information only in the 'Adverse Events' section - the data are deemed unreliable. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival at 18 Months | 18 months following the date of randomization. | Randomized Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Liver-specific Progression Free Survival (PFS) | From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months.. | The data set we received for analysis showed only 17 CIS-GEM participants and 16 SIRT+CIS GEM participants with reported liver tumor progression data available. Due to database issues, the validity and reliability of this data is not complete. | Days to first tumor progression | MEAN |
| SECONDARY | Progression Free Survival (PFS) at Any Site | From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months. | The data set we received for analysis showed 38 CIS-GEM participants and 27 SIRT+CIS GEM participants with reported tumor progression data available for any site. Due to database issues, the validity and reliability of this data is not complete | Days to tumor progression | MEAN |
| SECONDARY | Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver | From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months. | The data we received showed 85 of our 89 subjects with any RECIST data present. These data were not available nor complete for each visit due to early study termination and database issues. Any available data is reflected in the table. The validity and reliability of these data are not complete. | Number of Responses (RECIST 1.1+RRECIST) | COUNT_OF_UNITS |
| SECONDARY | Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site | From the date of first treatment until progression at any site, assessed up to 36 months. | The data we received showed 85 of our 89 subjects with any RECIST data present. These data were not available nor complete for each visit due to early study termination and database issues. Any available data is reflected in the table. The validity and reliability of these data are not complete. | Number of Responses (RECIST 1.1+RRECIST) | COUNT_OF_UNITS |
| SECONDARY | Overall Survival | From date of randomization until the date of death from any cause, assessed up to 36 months. | Overall survival data assessed until 36 months can be calculated for 42 CIS GEM participants and 36 SIRT+CIS GEM participants due to early termination and database errors. The validity and reliability of these data are not complete. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Liver Surgical Resection and Ablation Rate | 18 months following the date of randomization. | Data were collected for only 14 unique patients within the study due to early study termination and database issues. Any available data are reflected in the table. The validity and reliability of these data are not complete. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Adverse Events (Safety and Tolerability) | Informed consent until 28 days post last dose of protocol chemotherapy. | The following endpoints reflects safety and tolerability data related to Adverse Event grade by category. Counts of participants with Grade 3 or higher adverse event severity by AE category by treatment arm are shown below. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival at 18 Months | Chemotherapy (Cisplatin-Gemcitabine) | Yes | 25 | Participants | |
| Survival at 18 Months | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | Yes | 23 | Participants | |
| Survival at 18 Months | Chemotherapy (Cisplatin-Gemcitabine) | No | 23 | Participants | |
| Survival at 18 Months | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | No | 18 | Participants | |
| Liver-specific Progression Free Survival (PFS) | Chemotherapy (Cisplatin-Gemcitabine) | 323 | Full Range 82 to 712 | Days to first tumor progression | |
| Liver-specific Progression Free Survival (PFS) | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 369 | Full Range 102 to 875 | Days to first tumor progression | |
| Progression Free Survival (PFS) at Any Site | Chemotherapy (Cisplatin-Gemcitabine) | 332 | Full Range 40 to 712 | Days to tumor progression | |
| Progression Free Survival (PFS) at Any Site | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 424 | Full Range 102 to 875 | Days to tumor progression | |
| Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver | Chemotherapy (Cisplatin-Gemcitabine) Total Subjects | Complete Response (CR) : RECIST 1.1 | 22 | Number of Responses (RECIST 1.1+RRECIST) | |
| Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | Complete Response (CR) : RECIST 1.1 | 10 | Number of Responses (RECIST 1.1+RRECIST) |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy (Cisplatin-Gemcitabine) | 48 | |
| Overall Study | STARTED | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 41 | |
| Overall Study | COMPLETED | Chemotherapy (Cisplatin-Gemcitabine) | 11 | |
| Overall Study | COMPLETED | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 9 | |
| Overall Study | NOT COMPLETED | Chemotherapy (Cisplatin-Gemcitabine) | 37 | |
| Overall Study | NOT COMPLETED | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 32 |
Source ClinicalTrials.gov
Adverse events256
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 | Anaemia | Blood and lymphatic system disorders | Chemotherapy (Cisplatin-Gemcitabine) | 31 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 24 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy (Cisplatin-Gemcitabine) | 2 | 48 | |
| other | Leukopenia | Blood and lymphatic system disorders | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 3 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy (Cisplatin-Gemcitabine) | 8 | 48 | |
| other | Neutropenia | Blood and lymphatic system disorders | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 7 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy (Cisplatin-Gemcitabine) | 7 | 48 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 8 | 41 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Chemotherapy (Cisplatin-Gemcitabine) | 3 | 48 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 0 | 41 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy (Cisplatin-Gemcitabine) | 28 | 48 |
| Total, all-cause mortality | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 24 | 41 |
| Total, other adverse events | Chemotherapy (Cisplatin-Gemcitabine) | 47 | 48 |
| Total, other adverse events | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 41 | 41 |
| Total, serious adverse events | Chemotherapy (Cisplatin-Gemcitabine) | 17 | 48 |
| Total, serious adverse events | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 21 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40812353 | DERIVED |
Source PubMed
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 |
|---|---|
| Chemotherapy (Cisplatin-Gemcitabine) vs Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine): deaths from any cause | Trial comparisons |
| Chemotherapy (Cisplatin-Gemcitabine) vs Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine): 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/NCT02807181
GET https://conductscience.org/api/trials/v1/NCT02807181/results?page=2