Clinical trial · Interventional
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin-gemcitabine | Drug | — | UNRESOLVED |
| Radiation: SIRT + chemotherapy (cisplatin-gemcitabine) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy (Cisplatin-Gemcitabine)
- description
- 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.
- interventionNames
- Drug: Cisplatin-gemcitabine
- type
- EXPERIMENTAL
- label
- Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine)
- description
- 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.
- interventionNames
- Drug: Cisplatin-gemcitabine
- Device: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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 * 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.
References
Publications (1)
- DERIVEDBlair 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. PMID 40812353