Phase I/II study of S-IROX as second-line therapy after nab-Paclitaxel + Gemcitabine for unresectable pancreatic cancer

Phase I/II study of S-IROX as second-line therapy after nab-Paclitaxel + Gemcitabine for unresectable pancreatic cancer - 2nd-line S-IROX Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036969

Enrollment

Registered

2019-06-05

Start date

2019-06-10

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

The unresectable advanced pancreatic cancer after first-line Nab-Paclitaxel+Gemcitabine failure

Interventions

L-OHP:dose escalation CPT-11:dose escalation TS-1:fixed dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histological or cytologically proved pancreatic cancer adenocarcinoma or adenosquamous carcinoma Second-line chemotherapy for pancreatic cancer after nab-Paclitaxel and Gemcitabine Age 20-75 years ECOG Performance Status (PS) 0-1 Meets the following criteria within 14 days before enrollment absolute neutrophil count <1500/microL, platelet count <75,000/microL, hemoglobin <9g/dl, bilirubin >2.0mg/dl, AST and ALT >150U/l, Creatinine >1.2mg/dl, Creatinine clearance test <50ml/min Hemotype of UGT1A1 genotype is not including *6/*6, *28/*28, and *6/*28 Without anorexia 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 Municipal Hospital Department of Gastroenterology

mkobdkl@yahoo.co.jp058-251-1101

Outcome results

None listed

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