colorectal cancer
Conditions
Interventions
None listed
Sponsors
Japan Clinical Cancer Research Organization (JACCRO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Colorectal cancer pathologically (biopsy or cytology) confirmed to be adenocarcinoma (2) All of the following used in previous treatments: fluoropyrimidine, oxaliplatin, irinotecan*1, and angiogenesis inhibitors However, if the patient has the RAS/BRAF wild type, a BRAF mutation, is HER2 positive, or is MSI-high, the following criteria must be satisfied. If the RAS/BRAF wild type is present, the patient was previously treated with an anti-EGFR antibody drug. If a BRAF mutation is present, the patient previously received concomitant BRAF inhibitor therapy. If the patient is HER2 positive, the patient was previously treated with an anti-HER antibody. If the patient is MSI-high, the patient was previously administered an immune checkpoint inhibitor. *1 In cases such as an antibody-drug conjugate (ADC), irinotecan administration may be omitted if the payload is a topoisomerase I inhibitor. *2 In the case of HER2 positive, anti-EGFR therapy is not required. *3 In case the patient has the RAS/BRAF mutation, anti-HER2 antibody therapy is not required. (3) Patients who satisfy any of 1) to 3) below. 1) Recently received FTD/TPI plus bevacizumab therapy and determined to be refractory to or intolerant of this therapy (=> corresponds to cohort A) 2) Previously administered neither regorafenib nor FTD/TPI (=> corresponds to cohort B) 3) Administered regorafenib monotherapy after FTD/TPI +- bevacizumab and determined to be refractory to or intolerant of regorafenib monotherapy (=> corresponds to cohort B) (4) ECOG Performance Status of 0 to 2 (5) Aged 18 years or older at time of consent (6) Measurable or evaluable lesions according to RECIST version 1.1 (7) Patients who have given their written consent.
Exclusion criteria
Exclusion criteria: (1) Has symptomatic or Grade2 or higher interstitial pneumonia or pulmonary fibrosis (2) History of acute myocardial infarction or acute coronary syndrome (e.g., unstable angina, coronary artery bypass surgery, stent placement) within 6 months (180 days) before enrollment (3) History of clinically significant congestive heart failure or cardiac arrhythmia within 6 months (180 days) before enrollment or current evidence of such a condition. However, non-symptomatic and/or rate-controlled atrial fibrillation and paroxysmal supraventricular tachycardia are exceptions. (4) History of a clinically significant thrombotic or cerebrovascular event within 6 months (180 days) before enrollment (5) Other malignancies (6) Active infection requiring systemic treatment (7) Positive for HBs antigen, HCV antibodies, or HIV antibodies (8) The investigator or a sub-investigator determines that the patient is unsuitable to safely participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival [cohort A] | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, disease control rate, depth of response, time to response, time to treatment failure, progression-free survival, and safety [cohort A]. Response rate, disease control rate, depth of response, time to response, time to treatment failure, progression-free survival, safety, and overall survival [for cohort B as a whole, for each treatment line, and by previous treatment history]. Progression-free survival and overall survival for post-treatment. | — |
Countries
Japan
Contacts
Public ContactYu Sunakawa
St. Marianna University School of Medicine Department of Clinical Oncology
Outcome results
None listed