Clinical trial · Interventional
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Advanced Pancreatic Cancer Patients Progressed After First-line Gemcitabine and S-1: A Randomized Controlled Study
NCT02558868CI-TRIAL-00033384completedPhase 2ClinicalTrials.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)
This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oxaliplatin + Irinotecan
- description
- Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w
- interventionNames
- Drug: Irinotecan
- Drug: Oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan
- description
- Irinotecan：180 mg/m2，iv 120 min，d1 q2w
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 1 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed advanced pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study. * Additional inclusion criteria were age 18 years or older * Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI) * Karnofsky performance status (KPS) of at least 70% * -Adequate renal function, adequate hepatic function, adequate bone marrow function Exclusion Criteria: * The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain * Hypersensitivity to study drugs * Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start) * National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy * Prior or concurrent malignancy (other than pancreatic cancer) * Female, pregnancy or breastfeeding.
References
Publications (1)
- RESULTOettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30. PMID 24982456