Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.

Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer. - Multicenter phase II study of neoadjuvant GEM+nab-PTX for resectable pancreatic cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028101

Enrollment

Registered

2017-08-15

Start date

2017-09-01

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

Invasive ductal adenocarcinoma

Interventions

gemcitabine and nab-paclitaxel therapy as neoadjuvant therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Resectable pancreatic cancer 2. Adenocarcinoma or adenosquamous carcinoma 3. Age 20-79 4. ECOG PS 0-1 5. Able to eat orally 6. Appropriate biliary drainage if bile duct obstructed 7. No apparent sensory or motor neuropathy 8. No history of chemotherapy within last 3 years 9. No prior therapy for pancreatic cancer 10. Meet all the criteria of laboratory examination 11. Informed consent by patient

Exclusion criteria

Exclusion criteria: 1. History of gemcitabine, nab-paclitaxel 2. Ongoing active other malignancy 3. Allergic to gemcitabine and nab- 4. Computed tomography contrast media allergy 5. poor control of diarrhea 6. Intestinal pneumonia 7. Moderate amount of ascites or pleural effusion 8. Active infection 9. Poor control of diabetes mellitus 10. Serious comorbid conditions 11.Myocardial infarction within last 6 months 12. Systemic steroid therapy 13. Serious psychiatric diseases 14. Planning a baby or pregnancy 15. Planning a baby 16. Judged unable to guarantee safety

Design outcomes

Primary

Measure	Time frame
2 year progression-free survival rate (the initial date in reckoning is set at the date of registration)	—

Secondary

Measure	Time frame
Overall survival from registration Radiological response rate R0 resection rate Histological response rate Protocol compliance Relative dose intensity Incidence of adverse events	—

Countries

Japan

Contacts

Public ContactHirochika Toyama

Kobe University Graduate School of Medicine Division of Hepato-biliary-pancreatic Surgery Department of Surgery

tymhr@me.com078-382-6302

Outcome results

None listed

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