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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02558868

Enrollment

Registered

2015-09-24

Start date

2015-09-01

Completion date

2017-12-31

Last updated

2018-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Brief summary

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.

Interventions

DRUGIrinotecan

DRUGOxaliplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall Survival	1 years

Secondary

Measure	Time frame
Progression Free Survival	1 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026