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

JRCT ID: jRCT1041230068

Registered date:09/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 09/08/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): The patients with pancreatic cancer showing CA19-9> 100U/ml will undergo neoadjuvant chemotherapy (GEM/ nab-PTX, 2 cycles (8 weeks); a cycle includes gemcitabine 1000mg/m2 and nab-pacritaxel 125mg/m2 per week, 3 times) . After the evaluation of efficacy and safety, patients will undergo surgical resection if CA19-9< 100U/ml and diagnosed as resectable. If CA19-9 remains >100U/ml, additional 2 cycles of chemotherapy will be administered. After the completion of 8 cycles of chemotherapy, patients will undergo surgical resection. In case that CA19-9 increases, tumor progress and severe adverse events occur suring the chemotherapy, surgical resection will be performed.

Outcome(s)

• Primary Outcome: 2-year overall survival

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ebata Tomoki