Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma

Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma - Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030551

Enrollment

Registered

2017-12-25

Start date

2018-01-04

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

pancreatic cancer

Interventions

nab-paclitaxel and gemcitabine are administered on day1,15,29,43. The dose of gemcitabine is 600mg/m2 and that of nab-paclitaxel is 75, 100, and 125 mg/m2 for cohort 1, 2, and 3, respectively. Radioth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) PDAC patients whose resectability were classified as BR or UR-LA based on multidetector-row CT and whose definite diagnosis were proven histologically 2) Age (20 years old or more and 85 years old or less) 3) Performance Status (ECOG): 0 or 1 4) Agreement of the subject after informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with allergy for nab-paclitaxel and gemcitabine 2) Patients with severe infection 3) Patients who are considered to be inappropriate for this study

Design outcomes

Primary

Measure	Time frame
existence of DLT	—

Secondary

Measure	Time frame
resection rate, overall survival, progression free survival, safety, histological effect	—

Countries

Japan

Contacts

Public ContactAoi Hayasaki

Mie university hospital hepatobiliary pancreatic and transplantation surgery

a-hayasaki@clin.medic.mie-u.ac.jp059-232-1111

Outcome results

None listed

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