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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
National Cancer Center Hospital East (003)
Kashiwa, Chiba, Japan
Chiba University Hospital (015)
Chiba, Japan
Chiba Cancer Center (011)
Chiba, Japan
National Hospital Organization Shikoku Cancer Center (013)
Ehime, Japan
National Hospital Organization Kyushu Cancer Center (005)
Fukuoka, Japan
Kanazawa University Hospital (008)
Ishikawa, Japan
Kanagawa Cancer Center (002)
Kanagawa, Japan
Aichi Cancer Center (007)
Nagoya, Japan
Osaka International Cancer Institute (009)
Osaka, Japan
Saitama Cancer Center (012)
Saitama, Japan
...and 4 more locations
Overall Response (OR)
OR is defined as complete response (CR) or partial response (PR), as assessed by the independent central review (ICR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Time frame: Through the end of study treatment (approximately 16 months after study start)
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