Phase II study of the neoadjuvant chemotherapy of GEM/nab-PTX for biol ogical borderline-resectable pancreatic cancer

Phase II study of the neoadjuvant chemotherapy of GEM/nab-PTX for biological borderline-resectable pancreatic cancer - NUPAT-10

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041230068

Enrollment

Registered

2023-08-09

Start date

2023-08-09

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 pancreatic cancer

Interventions

The patients with pancreatic cancer showing CA19-9> 100U/ml will undergo neoadjuvant chemotherapy (GEM/ nab-PTX, 2 cycles (8 weeks)

a cycle includes gemcitabine 1000mg/m2 and nab-pacritaxel 125mg/m2 per week, 3 times) . After the evaluation of efficacy and safety, patients will undergo surgical resection if CA19-9100U/ml, addition

D017024, D013502

neoadjuvant chemotherapy, surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) diagnosed as pancreatic cancer by imiging studies 2) patients without distant metastasis (M0) 3) resectable pancreatic cancer 4) CA19-9 >100U/ml 5) age of 20-80 6) PS (ECOG) 0 or 1 7) initial treatment for the disease 8) without other malignancies 9) normal oral ingestion 10) without major organ failures 11) agreed by the patients

Exclusion criteria

Exclusion criteria: 1) serious allergy for any drug 2) active other malignancies 3) active infectious disease 4) neuropathy (>Grade 2) 5) administered with atanazavir 6) bowel obstruction or paresis 7) uncontrolable acites or pleural effusion 8) uncontrolable diabetes, hypertention, chirrosis, renal failure, ischemic cardiac disease, interstitial pneumonia 9) pregnant or lactating women 10) unable to join the clinical trial due to psychological condition 11) diarrea (>Grade 2) 12) administerd with S1 13) any other reasons by which doctors identified as inadequate

Design outcomes

Primary

Measure	Time frame
2-year overall survival	—

Secondary

Measure	Time frame
cycles of neoadjuvant chemotherapy ratio of successful decrease of tumor marker ratio of the cessation of neoadjuvant chemotherapy efficacy of chemotherapy based on RECIST Relative Dose Intensity (RDI) frequency and degree of adverse events efficay of chemotherapy (imaging and pathological response) disease free survival median survival time 3-year and 5-year survival surgical complication completion ratio of postoperative adjuvant chemotherapy chenge in imaging study (SUVmax)	—

Measure

Time frame

cycles of neoadjuvant chemotherapy ratio of successful decrease of tumor marker ratio of the cessation of neoadjuvant chemotherapy efficacy of chemotherapy based on RECIST Relative Dose Intensity (RDI) frequency and degree of adverse events efficay of chemotherapy (imaging and pathological response) disease free survival median survival time 3-year and 5-year survival surgical complication completion ratio of postoperative adjuvant chemotherapy chenge in imaging study (SUVmax)

—

Contacts

Public ContactShoji Kawakatsu

Nagoya University Hospital

kawakatsu.shoji.u1@f.mail.nagoya-u.ac.jp+81-52-744-2222

Outcome results

None listed

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