Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer

Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer - 2nd-line nab-Ptx+Gem study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016624

Enrollment

Registered

2015-02-25

Start date

2015-02-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

advanced pancreatic cancer

Interventions

2nd-line nab-Ptx+Gem study

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histological or cytologically proved pancreatic cancer adenocarcinoma or adenosquamous carcinoma Inoperative cases of advanced pancreatic cancer Second-line chemotherapy for pancreatic cancer after FOLFIRINOX Age 20-75 years ECOG Performance Status (PS) 0-1 Meets the following criteria within 14 days before enrollment WBC count <12,000/microl, absolute neutrophil count >1,500/microl, platelet count >100,000/microl, hemoglobin >9g/dl, bilirubin <2.0mg/dl, AST and ALT <150U/l, Creatinine <1.5mg/dl, Creatinine clearance test >50ml/min Without anorexia Without peripheral neuropathy Normal ECG An agreement is provided

Exclusion criteria

Exclusion criteria: Pulmonary fibrosis or interstitial pneumonia Watery stool Infection Uncontrolled diabetes mellitus Any serious complication Pregnancy

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Overall survival Progression free survival The frequency of occurrence of complication	—

Countries

Japan

Contacts

Public ContactMitsuru Okuno

Gifu University Hospital First Department of internal Medicine

mkobdkl@yahoo.co.jp058-230-6308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026