転移性膵臓腺癌の治療歴のない日本人被験者を対象とした、イリノテカンリポソーム注射剤、オキサリプラチン、5-フルオロウラシル/レボロイコボリンの第2相試験

基本情報

NCT ID

NCT06225999

ステータス

実施中（募集終了）

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

41

治験依頼者名

Servier

概要

This study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (S095013) in combination with oxaliplatin, 5-Fluorouracil (5-FU) and levoisomer form of leucovorin (LLV). S095013, oxaliplatin, 5-FU and LLV will be administered on days 1 and 15 of each 28-day cycle. Cycles will continue until clinical or radiological progressive disease, unacceptable study medication-related toxicity or withdrawal from study. During the treatment period participants will have study visits on day 1, 3, 15, and 17 of each cycle, some of which may occur as a home visit. At least 30 days after treatment has ended a end of treatment visit will occur and then participants will be followed for survival every month via telephone or email until death or end of the study. Study visits may include questionnaires, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.

対象疾患

介入

依頼者（Sponsor）

実施施設 (13)