Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resection

Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resection - Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resection

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021305

Enrollment

Registered

2016-03-07

Start date

2016-04-01

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

Pancreatic cancer

Interventions

Intravenous administration of Gemcitabine and Nab-Pacritaxel on days 1, 8, 15 every 28days x 2 courses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) diagnosed aspancreatic duct adenocarcinoma (2) with difficulty of curative resection (3) without prior anticancer therapy for pancreatic cancer except for palliative therapy (4) Performance status 0 or 1 (5) age 20 and over (6) with more than 6 months survival at registration (7) tolerable for out patient chemotherapy (8) with judgement

Exclusion criteria

Exclusion criteria: (1) not diagnosed as pancreatic duct adenocarcinoma (2) recurrence (3) obvious distant metastasis (4) with prior anticancer therapy for pancreatic cancer (5) with other active cancer (6) with uncontrollable infection (7) with hypersensitivity for pacritaxel or albmin (8) pregnancy, postpartum within 28 days or lactating (9) expected survival within 6 months (10) difficult for out patient chemotherapy (11) age < 20 (12) without judgement (13) determined to be inappropriate as a subject

Design outcomes

Primary

Measure	Time frame
overall survival at 2-year after registration	—

Secondary

Measure	Time frame
All the registration cases -The rate of adverse events -The rate of resolution of curative resection difficulty -The rate of intention for curative resection -The rate of primary tumor resection -Overall survival -Chantes in tumor marker -Tumor shrinkage All the resection cases -The rate of R0 resection -The rate of Lymph node metastasis -Histological response -Relapse free survival -The type of recurrence	—

Measure

Time frame

All the registration cases -The rate of adverse events -The rate of resolution of curative resection difficulty -The rate of intention for curative resection -The rate of primary tumor resection -Overall survival -Chantes in tumor marker -Tumor shrinkage All the resection cases -The rate of R0 resection -The rate of Lymph node metastasis -Histological response -Relapse free survival -The type of recurrence

—

Countries

Japan

Contacts

Public ContactFuyuhiko Motoi

Tohoku University Graduate School of Medicine Surgery

motoi@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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