Phase I study of neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel for patients with borderline resectable pancreatic cancer

Phase I study of neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel for patients with borderline resectable pancreatic cancer - NAC-GEMABR

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018382

Enrollment

Registered

2015-07-22

Start date

2015-07-01

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 carcinoma

Interventions

neoadjuvant chemotherapy 2 courses of NAC-GEMABR 1. nab-paclitaxel(Day1,8,15)125mg/m2 30min administration 2. Gemcitabine(Day1,8,15)1000mg/m2 30min administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically proven invasive pancreatic ductal carcinoma 2. Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) 1) Definition of a borderline resectable pancreatic cancer is filled in NCCN guideline version 1.2014 pancreatic adenocarcinoma 2) Patients indicated distal pancreatectomy with en bloc celiac axis resection 3. PS (ECOG) 0-1 4. >=20 years old and < 80 years old 5. First line treatment 6. The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count <=12,000/mm3 Neutrophil count >=1,500/mm3 Platelet count >=100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine <=upper limits of normal(ULN) AST, ALT<=2.5xULN Albumin>=3.0g/dL Hemoglobin>=9.0g/dL 7. Written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Severe drug hypersensitivity 2. Multiple primary cancers within 5 years 3. Severe infection 4. With grade2 or more severe peripheral neuropathy 5. With intestinal paralysys, ileus 6. Interstitial pneumonia or pulmonary 7. With uncontrollable pleural effusion or ascites 8. Receiving atazanavir sulfate 9. With uncontrollable diabetes 10.With uncontrollable heart failure, angina, hypertension, arrhythmia 11.With severe psychological symptoms 12.With watery diarrhea 13.Pregnant or lactating women, or women with known or suspected pregnancy 14.Inappropriate patients for entry on this study in the judgment of the investigator

Design outcomes

Primary

Measure	Time frame
Adverse event	—

Secondary

Measure	Time frame
1. R0 resection rate 2. Resection rate 3. Optimal duration before surgery to perform neoadjuvant chemotherapy 4. QOL evaluation about peripheral neuropathy using FACT-NTX(Version4)	—

Countries

Japan

Contacts

Public ContactKen-ichi Okada

Wakayama Medical University Second Department of Surgery

okada@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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