Intrahepatic CholangiocarcinomaPhase 2/3SIRCCANCT02807181
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
A Phase 2/3 study testing Cisplatin-gemcitabine and Radiation: SIRT + chemotherapy (cisplatin-gemcitabine) in people with Intrahepatic Cholangiocarcinoma, run by Sirtex Medical at 23 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Cisplatin-gemcitabine and Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 14 Feb 2017to 29 Apr 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Willing, able and mentally competent to provide written informed consent.
- Aged 18 years or older.
- Histologically or cytologically confirmed unresectable and non-ablatable intrahepatic cholangiocarcinoma.
- Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patient are permitted to have loco-regional lymph node involvement defined as: portal LN </= to 2 cm and/or para aortic LN </= to 1.5 cm in longest diameter, and/or up to 2 indeterminate lung lesions < 1 cm if these lung lesions are positron emission tomography (PET) negative.
- Chemotherapy naïve. Adjuvant chemotherapy is not permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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- Adequate hematological function defined as:
- Hemoglobin >/= 10g/dL White Blood Cell count (WBC) >/= 3.0 x 10^9/L Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L Platelet count >/= 100,000/mm^3 - Adequate liver function defined as: Total bilirubin </= 30 umol/L (1.75 mg/dL) Albumin >/= 30 g/L
- Adequate renal function defined as: Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN) Creatinine clearance >/= 45 ml/min (calculated with Cockcroft-Gault Equation)
- Life expectancy of at least 3 months without any active treatment
- Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active use an acceptable method of contraception during the study.
- Male patients must be surgically sterile or if sexually active must use an acceptable method of contraception during the study.
- Considered suitable to receive either regimen in the clinical judgement of the treating investigator.
Who cannot join
- Patients with only non-measurable lesions in the liver according to RECIST criteria
- Incomplete recovery from previous liver surgery, e.g. unresolved biliary tree obstruction or biliary sepsis or inadequate liver function
- Biliary stent in situ
- Main trunk Portal Vein Thrombosis (PVT)
- Ascites, even if controlled with diuretics. (A minor peri-hepatic rim of ascites detected at imaging is acceptable).
- Mixed hepatocellular carcinoma - intrahepatic cholangiocarcinoma (HCC-ICC) disease
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- History of prior malignancy. Exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, recurrent intra-hepatic cholangiocarcinoma post local treatment or any early stage (stage 1) malignancy adequately resected with curative intent at least 5 years prior to study entry
- Suspicion of any bone metastasis/metastases or central nervous system metastasis/metastases on clinical or imaging examination.
- Prior internal or external radiation delivered to the liver.
- Pregnancy; breast feeding.
- Participation within 28 days prior to randomization, in an active part of another clinical study that would compromise any of the endpoints of the study.
- Evidence of ongoing active infection that may affect treatment feasibility or outcome.
- Prior Whipple's procedure.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
France11 sites
Hopital Beaujon
Clichy, 92110
CHU Dijon
Dijon, 21079
CHU de Grenoble
Grenoble, 38043
CHU Lyon - Hospital de la Croix-Rousse
Lyon, 69317
Institut Paoli Calmettes
Marseille, 13009
CHU Montpellier
Montpellier, 34295
CHU Nice - Hopital l'Archet 2
Nice, 06202
Hopital Haut-Leveque
Pessac, 33604
CHU de Poitiers
Poitiers, 86021
Centre Eugene Marquis Hospital de Jour
Rennes, 35042
Hopital Paul Brousse
Villejuif, 94800
United Kingdom4 sites
Hammersmith Hospital Imperial College Healthcare NHS Trust
London, W12 0HS
The Christie NHS Foundation Trust
Manchester, M20 4BX
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY
Southampton General Hospital
Southampton, S016 6YD
Australia2 sites
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Macquarie University Hospital
North Ryde, New South Wales, 2109
Spain2 sites
Hospital Clinic Barcelona
Barcelona, 08036
Clinica Universitaria de Navarra
Pamplona, 31008
About this study
Official title: Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
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.
Read the detailed description
This clinical study was a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma.
Randomized patients were to be followed until death, withdrawal of consent, or until end of study.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Cisplatin-gemcitabine, Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin-gemcitabineDrug
Also called CIS-GEM
Systemic chemotherapy
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)Device
SIR-Spheres microspheres followed by systemic chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy (Cisplatin-Gemcitabine) | Active comparator | Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle. Receives: Drug: Cisplatin-gemcitabine |
| Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine) | Experimental | A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion. Receives: Drug: Cisplatin-gemcitabine; Device: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 18 Months
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.
Measured: 18 months following the date of randomization.
Secondary outcomes (7)
Liver-specific Progression Free Survival (PFS)
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.
Measured: 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..
Progression Free Survival (PFS) at Any Site
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.
Measured: 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.
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
The outcome was not analyzed due to unreliability of the clinical database.
Measured: From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months.
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
The outcome was not analyzed due to unreliability of the clinical database.
Measured: From the date of first treatment until progression at any site, assessed up to 36 months.
Overall Survival
The outcome was not analyzed due to unreliability of the clinical database.
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months.
Liver Surgical Resection and Ablation Rate
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.
Measured: 18 months following the date of randomization.
Incidence of Adverse Events (Safety and Tolerability)
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.
Measured: Informed consent until 28 days post last dose of protocol chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start14 Feb 2017
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordi Bruix, MD, Principal investigator, Head of the Hepatic Oncology Unit, Hospital ClinicHarpreet Wasan, MD, Principal investigator, Imperial College Healthcare Hammersmith Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807181
- Sponsor's protocol ID
- STX0115
- Acronym
- SIRCCA
- Status last verified
- Apr 2025
- First submitted
- 13 May 2016
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.
PubMed 40812353
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT02807181
- Acronym / sponsor ID
- SIRCCA / STX0115
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Sirtex MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical study was a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma.
Randomized patients were to be followed until death, withdrawal of consent, or until end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy (Cisplatin-Gemcitabine) | Active comparator | Drug: Cisplatin-gemcitabineCisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle. |
| Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine) | Experimental | Drug: Cisplatin-gemcitabine, Device: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing, able and mentally competent to provide written informed consent.
- Aged 18 years or older.
- Histologically or cytologically confirmed unresectable and non-ablatable intrahepatic cholangiocarcinoma.
- Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patient are permitted to have loco-regional lymph node involvement defined as: portal LN </= to 2 cm and/or para aortic LN </= to 1.5 cm in longest diameter, and/or up to 2 indeterminate lung lesions < 1 cm if these lung lesions are positron emission tomography (PET) negative.
- Chemotherapy naïve. Adjuvant chemotherapy is not permitted.
Key exclusion criteria (13 listed)
- Patients with only non-measurable lesions in the liver according to RECIST criteria
- Incomplete recovery from previous liver surgery, e.g. unresolved biliary tree obstruction or biliary sepsis or inadequate liver function
- Biliary stent in situ
- Main trunk Portal Vein Thrombosis (PVT)
- Ascites, even if controlled with diuretics. (A minor peri-hepatic rim of ascites detected at imaging is acceptable).
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 |
|---|---|---|
| Cisplatin-gemcitabineAlso: CIS-GEMSystemic chemotherapy | Drug | Chemotherapy (Cisplatin-Gemcitabine), Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine) |
| Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)SIR-Spheres microspheres followed by systemic chemotherapy | Device | Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine) |
Primary outcome
Survival at 18 Months
Time frame: 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.
7 secondary outcomes
Liver-specific Progression Free Survival (PFS)
Time frame: 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..
Progression Free Survival (PFS) at Any Site
Time frame: 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.
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
Time frame: From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months.
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
Time frame: From the date of first treatment until progression at any site, assessed up to 36 months.
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.
Liver Surgical Resection and Ablation Rate
Time frame: 18 months following the date of randomization.
Incidence of Adverse Events (Safety and Tolerability)
Time frame: Informed consent until 28 days post last dose of protocol chemotherapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40812353Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.
- Individual participant dataSharing planned: No
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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.
Jordi Bruix, MD principal investigator
Head of the Hepatic Oncology Unit, Hospital Clinic
Harpreet Wasan, MD principal investigator
Imperial College Healthcare Hammersmith Hospital
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cisplatin-gemcitabine and Radiation: SIRT + chemotherapy (cisplatin-gemcitabine) in people with Intrahepatic Cholangiocarcinoma, run by Sirtex Medical at 23 sites in 8 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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, United Kingdom, Australia, Spain, United States and 3 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival at 18 Months (time frame: 18 months following the date of randomization.). 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 NCT02807181, which also lists 1 linked publication.
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 9 May 2025.