For second-line chemotherapy of Nanoliposomal irinotecan with fluorouracil compared to S-1 for unresectable advanced pancreatic cancer

JRCT ID: jRCT1041210132

Registered date:19/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic canser
• Date of first enrollment: 19/01/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Assignment between S-1 treatment group and Nanoliposomal irinotecan with fluorouracil treatment group

Outcome(s)

• Primary Outcome: Progression-free survival (PFS)

Secondary Outcome

Health-related quality of life (EQ-5D, EORTC-C30), overall survival (OS),
Treatment success period (TTF), response rate (RR), frequency and extent of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients received sufficient explanation, and then obtained written inforned consent by with sufficient understanding.
2. Patients aged 20 at the time of inforned consent
3. Patients diagnosed with pancreatic cancer based on the diagnostic criteria for pancreatic cancer
4. Contains anti-cancer agents other than S-1 or S-1 + other for unresectable advanced pancreatic cancer
. Implementation of neoadjuvant chemotherapy with anticancer drugs other than S-1
If it worsens and is judged to be unresectable, it is considered as initial treatment and registered.
5. Patients with ECOG Performance Status (PS) 0-2.
6. Cases in which the functions of major organs are sufficiently maintained.

1 White blood cell count: 3,500 / mm3 or more
2 Number of neutrophils: 2,000 / mm3 or more
3 Amount of hemoglobin: 9.0 g / dL or more
4 Platelet count: 100,000 / mm3 or more
5 Total bilirubin value: 2.0 mg / dL or less
6 AST and ALT values: 150 U / L or less

Exclude criteria

1. Patients who have a history of intestinal obstruction or undergone of resection of pancreatic canser.
2. Patients who have been receiving radiation therapy.
3. Other patients who are judged to be inappropriate by the investigator.

Related Information

• Primary Sponsor: Hirooka Yoshiki