Clinical trial · Interventional
HAIC Versus Systemic Chemotherapy for Unresectable ICC
Hepatic Arterial Infusion Chemotherapy of Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Oxaliplatin for Unresectable Intrahepatic Cholangiocarcinoma
NCT03771846CI-TRIAL-00042079unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.
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 |
|---|---|---|---|
| gemcitabine and oxaliplatin | Drug | — | UNRESOLVED |
| irinotecan, oxaliplatin , fluorouracil, and leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hepatic artery infusion chemotherapy
- description
- Participants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin
- interventionNames
- Drug: irinotecan, oxaliplatin , fluorouracil, and leucovorin
- type
- ACTIVE_COMPARATOR
- label
- Systemic chemotherapy
- description
- Participants received systemic chemotherapy of gemcitabine and oxaliplatin
- interventionNames
- Drug: gemcitabine and oxaliplatin
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The diagnosis of ICC * Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria. * With no previous treatment * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * Without distant metastasis, but intrahepatic lymph node metastasis is allowed * The following laboratory parameters: Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Exclusion Criteria: * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
References
Publications (0)
Data not yet available
No reference posted for this study.