The phase I,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer

Phase 1

• Conditions: ocally-advanced pancreas cancer; Pancreas cancer, locally advanced

• Registration Number: JPRN-jRCTs061180045
• Lead Sponsor: Kondo Naru

Brief Summary

Phase 1: gemcitabine+nab-paclitaxel+S-1 chemotherapy showed good preliminary efficacy with mild toxicity in this study, and warrants a further phase 2 trial to investigate the efficacy of the gemcitabine+nab-paclitaxel+S-1 regimen for locally advanced pancreas cancer. Phase 2: The neoadjuvant GAS chemotherapy regimen for locally advanced pancreas cancer showed good efficacy with mild toxicity, resulting in a high R0 resection rate and prolonged survival in patients with locally advanced pancreas cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-12
• Study Completion: 2020-12-31
• Results First Posted: 2021-10-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Histologically confirmed pancreatic cancer
2. Locally advanced pancreatic cancer on imaging examinations
3. Performance status (ECOG): 0 or 1
4. Initial therapy
5. Agreement with signature of applicant has obtained before initiation of therapy

Exclusion Criteria

(1)Severe allergy for medicine
(2)Patients with other malignant disease within 5 years
(3)Patients with active infection
(4)Patients with severe neuropathy (>Grade2)
(5)Patients with ileus
(6)Patients with interstitial pneumonia
(7)Patients with uncontrollable ascites or pleural fluid
(8)Patients with uncontrollable diabetes
(9)Patients with uncontrollable heart disease
(10)Patients with pregnant or possibly pregnant
(11)Patients who have judged not suitable for this study by doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I: incidence of adverse event which apply for discontinuance criteria <br>Phase II: Two year survival rate, median survival time

Secondary Outcome Measures

Name	Time	Method
All adverse events, Resection rate, R0 resection rate, response rate, histological efficacy