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Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer

Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer - Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016852
Enrollment
24
Registered
2015-03-23
Start date
2015-03-23
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 unresectable pancreatic cancer

Interventions

Patients receiving nab-PTX plus gemcitabine will receive 125 mg/m2, nab-PTX as a 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30-

Sponsors

Kurume university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histlogically proven adenocarcinoma or adeno-squamous carcinoma 2) Unresectable locally advanced pancreatic cancer 3) No prior chemotherapy and radiotherapy for other malignancies 4) Age upper 20 and less than 80 5) ECOG performance status of 0, 1 6) Adequate hematologic, hepatic and renal function 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with Distant metastasis 2) Patients with symptomatic pulmonary fibrosis or interstitial pneumonia 3) Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 4) Patients has severe complications, such as heart failure, renal failure ileus and severe mental disorder 5) History of malignancy in the last 3 years 6) History of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease). 7) History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa). 8) Women who are pregnant or expect to be pregnant, or nursing female 9) Others

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Overall survival, progression free survival, adverse events

Countries

Japan

Contacts

Public ContactMasaru Fukahori

Kurume university school of medicine Division of gastroenterology, multidisciplinary cancer treatment center

digdug0526@gmail.com0942-31-7561

Outcome results

None listed

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