Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer

Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer - GABARNANCE Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026858

Enrollment

110

Registered

2017-04-06

Start date

2017-04-15

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

Borderline Resectable Pancreatic Cancer

Interventions

gemcitabine and nab-paclitaxel therapy as neoadjuvant therapy S-1 and concurrent radiotherapy as neoadjuvant therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Borderline resectable pancreatic cancer 2. Adenocarcinoma or adenosquamous carcinoma 3. No distant metastasis 4. Age 20-79 5. ECOG PS 0-1 6. No prior abdominal radiation therapy 7. No history of chemotherapy within last 3 years 8. No prior therapy for pancreatic cancer 9. Included in the irradiation field of 10cm x10cm 10. Able to eat orally 11. No sensory or motor neuropathy 12. Appropriate biliary drainage if bile duct obstructed 13. No radiological evidence of apparent intestinal cancer invasion and history of gastrointestinal bleeding 14. Meet all the criteria of laboratory examination 15. Informed consent by patient

Exclusion criteria

Exclusion criteria: 1. History of gemcitabine, nab-paclitaxel and fluorouracil 2. poor control of diarrhea 3. Use of Coumadin, Phenytoin and Flucytosine 4. Allergic to gemcitabine and nab-paclitaxel 5. Computed tomography contrast media allergy 6. Intestinal pneumonia 7. Moderate amount of ascites or pleural effusion 8. Active infection 9. Poor control of diabetes mellitus 10. Ongoing active other malignancy 11. Active peptic ulcer 12. Serious comorbid conditions 13. Myocardial infarction within last 6 months 14. Systemic steroid therapy 15. Serious psychiatric diseases 16. Planning a baby or pregnancy 17. Planning a baby 18. Judged unable to guarantee safety

Design outcomes

Primary

Measure	Time frame
PhaseII part: R0 resection rate PhaseIII part: Overall survival	—

Secondary

Measure	Time frame
PhaseII part: Incidence of adverse events PhaseIII part: Progression free survival, R0 resection rate, 2 year survival rate, Radiological response rate, Histological response rate, Incidence of adverse events, Protocol compliance (completion rate of neoadjuvant therapy and overall therapy)	—

Countries

Japan

Contacts

Public ContactYusuke Hashimoto

National Cancer Center Hospital East Division of Hepatobiliary and Pancreatic Oncology

yushashi@east.ncc.go.jp+81-471-33-1111

Outcome results

None listed

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