TAS-CC5 Study

JRCT ID: jRCT1031220613

Registered date:06/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 10/11/2022
• Target sample size: 105
• Study type: Observational

Outcome(s)

• Primary Outcome: progression free survival
• Secondary Outcome: Response rate , overall survival, and incidence of Grade 3 neutropenia

Key inclusion & exclusion criteria

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

Include criteria

1)Histologically proven colorectal cancer
2)patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
3)treatment history of two or more regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study
4)Patients with unresectable advanced recurrent colorectal cancer who have become refractory or intolerant to fluoropyrimidine anticancer drugs, oxaliplatin, irinotecan, and angiogenesis inhibitors (bevacizumab, ramucirumab, or aflibercept).
5)20< and 80> years old
6)ECOG performance status of 0 or 1
7)With measurable lesions according
8)ability to tolerate oral drug administration
9)a life expectancy of at least 3 months
10)Patient who has adequate main organ functions in tests within 14 days beforeenrollment
leukocyte >3,000/mm3
neutrophil >1,000/mm3
platelet >75,000/mm3
haemoglobin concentorarion >8.0 g/dL
serum total bilirubin level <1.5 mg/dLserum creatinine <1.5 mg/dL
serum AST and ALT levels <5x Upper limit of normal (ULN).
serum creatinine <1.5 mg/dL
Peripheral neuropathy<grade2
Diarrhea and NonHaematotoxicity <grade1
11)gave written informed consent

Exclude criteria

1)contraindications for FTD/TPI and Bevacizumab
2)previously received chemotherapy with FTD/TPI
3)severe drug allergy
4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy.
5)patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.)
6)have pleural effusion and ascitic fluid with the treatment
7)Comorbidity or history of heart failure
8)gastrointestinal ulcer or bleeding
9)previous hemoptysis
10)Clinical or radiological evidence of CNS metastases
11)Current or previous (within the last 6 months) history of GI perforation
12)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
13)ongoing treatment with anticoagulant
14)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
15)Under continuous steroid administration
16)decision of unsuitable for this study by the investigator

Related Information

• Primary Sponsor: Takeshi Yamada