Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Kochi University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Pancreatic Adenocarcinoma

Treatments: Drug: GnP; Drug: GS

Study type: Interventional

Funder types: Other

Identifiers

NCT05268692

GSGnP

Details and patient eligibility

About

The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.

Full description

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

elective pancreatectomy for pancreatic cancer

Exclusion criteria

a previous cancer surgery a body weight loss of >10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

GS

Active Comparator group

Description:

gemcitabine plus S-1

Treatment:

Drug: GS

GnP

Active Comparator group

Description:

gemcitabine plus nab-paclitaxel

Treatment:

Drug: GnP