E-BiTS study

JRCT ID: jRCTs041220085

Registered date:01/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 09/11/2022
• Target sample size: 36
• Study type: Interventional
• Intervention(s): Patients will receive biweekly FTD/TPI (35mg twice daily on days 1-5, every 2 weeks) with BEV (5mg/kg on day 1, every 2weeks).Between second cycles and fourth cycles, the dose of FTD/TPI will be escalated if patients meet criteria of FTD/TPI dose escalation.

Outcome(s)

• Primary Outcome: Disease control rate

Secondary Outcome

Overall survival: OS
Progression free survival: PFS
Response rate: RR
Relative Dose Intensity: RDI
Increase implementation rate
Adverse effect (AE) occurrence rate

Key inclusion & exclusion criteria

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

Include criteria

1) Patients has been diagnosed with unresectable advanced or recurrent colorectal adenocarcinoma by histopathological diagnosis.
2) The age of patients on registration date is 20 years or older.
3) ECOG PS 0 or 1.
4) Patients have measurable lesions.
5) Patients have a history of refractory or intolerant to the following chemotherapy.
(1) All three drugs, fluorinated pyrimidine anticancer drug, oxaliplatin, and irinotecan
(2) Angiogenesis inhibitor (bevacizumab, ramucirumab, or aflibercept)
(3) Anti-EGFR antibody drug (cetuximab or panitumumab) in RAS wild type
(4) BRAF inhibitor (encorafenib) in BRAF mutant
(5) Immune checkpoint inhibitors (pembrolizumabor nivolumab) in MSI-H
6) Patients who have not been treated with FTD/TPI.
7) Patients who can take orally
8) Patients are expected to live for 3 months or longer
9) Patients whose latest test values within 14 days before registration meet all of the following.
(1) Number of neutrophils >= 1500/mm3
(2) Platelet count >= 75000/mm3
(3) Total bilirubin <= 1.5 mg / dL
(4) AST <= 100 U/L
(5) ALT <= 100 U/L
(6) Serum creatinine <= 1.5 mg/dL and Ccr >= 60mL/min
(7) Urine protein (test paper method) 1+ or less, or UPC (Urine Protein Creatinine) ratio <= 2.0
10) Patients have given written consent to participate in the study.

Exclude criteria

1) Patients with double cancers requiring chemotherapy (excluding hormone therapy)
2) Patients have infectious diseases which need systemic treatment.
3) Patients have difficulty in being enrolled in this study due to clinically problematic mental illness
4) Patients with the following complications
(1) Renal failure
(2) Cirrhosis / liver failure
(3) Chronic lung disease requiring oxygen administration
(4) Concomitant with unstable angina (angina whose onset or seizures have worsened within the last 3 weeks) or a history of myocardial infarction within 6 months
(5) Other complications that the doctor in charge considers to be serious
5) Patients receiving continuous systemic administration of steroids or immunosuppressants
6) Patients with unstable thromboembolism.
7) Pregnant women, lactating women, women who may be pregnant now, or patients who are not willing to use contraception
8) Patients judged by the investigator to be inappropriate

Related Information

• Primary Sponsor: Taniguchi Hiroya