A phase II trial of Down staging Chemotherapy with Nab-paclitaxel plus Gemcitabine in patients with locally advanced pancreatic cancer

A phase II trial of Down staging Chemotherapy with Nab-paclitaxel plus Gemcitabine in patients with locally advanced pancreatic cancer - A phase II trial of GnP down staging chemotherapy for patients with locally advanced pancreatic cancer (CAP-005)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022241

Enrollment

Registered

2016-05-08

Start date

2016-05-23

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

locally advanced pancreatic cancer

Interventions

1)Down staging chemotherapy: 3 course of gemcitabine and nab-PTX combination therapy (21days for one course:day1, day8 nab-PTX:125mg/m2/day+GEM:1000mg/m2/day) or total six time administration 2)Surgi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Invasive ductal carcinoma or invasive intraductal papillary-mucinors carcinoma proved by Radiological examination (enhanced CT or MRI) 2)No distant metastasis 3)Borderline or unresectable locally advanced pancreatic cancer tumor abutment of the SMA, HA, CEA tumor involving PV or SMV (diameter of encased PV or SMV are less than 50% of adjacent normal PV or SMV diameter. 4)patients who can tolerate the pancreatic surgery. 5)Age more than 20 or less than 80 6)No history of primary chemo therapy and/or radiation therapy. 7)ECOG performance status 0-1 8)Adequate organ function 9)Without problems for oral medication 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)History of sever allergic reaction with gemcitabine, nab-paclitaxel or S-1 2)Pregnant females, possibly pregnant females, females wishing to become pregnant, and females feeding babies. 3)Pulmonary fibrosis or interstitial pneumonia 4)History of breast or lung radiation 5)Active infection 6)Patients with pleural effusion 7)Active double cancer 8)Patients with positive for HBs antigen 9)Patients under treatment with phenytoin or walfarin 10)Uncontrolled heart diseases such as angina, myocardial infarction within three months, and cardiac dysfunction 11)Uncontrolled diabetes or hypertension 12)Sever mental disorder 13)Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
resection rate (R0+1), overall survival, disease free survival, pathological chemotherapy effect, adverse events, complication rate, tumor marker, tumor response rate, relative dose intensity, rate of protocol achievement, recurrence type, positive rate of lymph node	—

Countries

Japan

Contacts

Public ContactShigetsugu Takano

Chiba unviersity, Graduate School of Medicine Department of General Surgery

stakano@faculty.chiba-u.jp81-43-222-7171

Outcome results

None listed

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