Phase II study of the neoadjuvant chemotherapy of GEM/nab-PTX for biological borderline-resectable pancreatic cancer

Phase 2

Recruiting

• Conditions: pancreatic cancer; C535836

• Registration Number: JPRN-jRCT1041230068
• Lead Sponsor: Ebata Tomoki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) diagnosed as pancreatic cancer by imiging studies
2) patients without distant metastasis (M0)
3) resectable pancreatic cancer
4) CA19-9 >100U/ml
5) age of 20-80
6) PS (ECOG) 0 or 1
7) initial treatment for the disease
8) without other malignancies
9) normal oral ingestion
10) without major organ failures
11) agreed by the patients

Exclusion Criteria

1) serious allergy for any drug
2) active other malignancies
3) active infectious disease
4) neuropathy (>Grade 2)
5) administered with atanazavir
6) bowel obstruction or paresis
7) uncontrolable acites or pleural effusion
8) uncontrolable diabetes, hypertention, chirrosis, renal failure, ischemic cardiac disease, interstitial pneumonia
9) pregnant or lactating women
10) unable to join the clinical trial due to psychological condition
11) diarrea (>Grade 2)
12) administerd with S1
13) any other reasons by which doctors identified as inadequate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year overall survival

Secondary Outcome Measures

Name	Time	Method
cycles of neoadjuvant chemotherapy<br>ratio of successful decrease of tumor marker<br>ratio of the cessation of neoadjuvant chemotherapy<br>efficacy of chemotherapy based on RECIST<br>Relative Dose Intensity (RDI)<br>frequency and degree of adverse events<br>efficay of chemotherapy (imaging and<br>pathological response)<br>disease free survival<br>median survival time<br>3-year and 5-year survival<br>surgical complication<br>completion ratio of postoperative adjuvant chemotherapy<br>chenge in imaging study (SUVmax)