SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
TerminatedPhase 2, PHASE3Results postedLast updated 9 May 2025
What this trial tests
Phase 2, PHASE3 trial testing Cisplatin-gemcitabine in Intrahepatic Cholangiocarcinoma in 89 participants. Terminated before completion.
18 and older, any sex, with Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Survival at 18 MonthsPrimary· 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.
Liver-specific Progression Free Survival (PFS)Secondary· 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.
Progression Free Survival (PFS) at Any SiteSecondary· 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.
Objective Response Rate by RECIST 1.1 and Refined RECIST - LiverSecondary· 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.
Complete Response (CR) : RECIST 1.1
Group
Value
95% CI
Chemotherapy (Cisplatin-Gemcitabine) Total Subjects
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any SiteSecondary· 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.
Liver Surgical Resection and Ablation RateSecondary· 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.
Incidence of Adverse Events (Safety and Tolerability)Secondary· 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.
Time frame: Up to 3.6 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study planned to evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients were randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients were randomized to CIS-GEM alone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other Sirtex Medical trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sirtex Medical
Last refreshed: 9 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02807181.