advanced colorectal cancer
Conditions
Interventions
1 cycle is 28days. Nintedanib (150mg or 200mg) is orally administered twice daily and TAS-102 (35mg/m2) is orally administered twice daily in 1-5days and 8-12 days
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Written informed consent 2)>=20 years old 3)Histologically or cytologically proven adenocarcinoma of colon or rectum (except appendiceal cancer), and KRAS test were carried out. 4)Prior chemotherapy was discontinued due to disease progression, or an adverse event. 5)No prior treatment with Regorafenib 6)ECOG Performance Status of 0 or 1 7)Adequate oral intake 8)With measurable disease according to RECIST 9)Adequate organ function within 14 days prior to enrollment. a.Hemoglobin >=9.0 g/d b.Absolute neutrophil count >=1,500 /mm3 c.Platelet count >=100,000 /mm3 d with no liver metastasis, AST/ALT<=ULNx1.5 and T-Bil<=UNL with liver metastasis, AST/ALT<=ULNx2.5 and T-Bil<=UNL e Serum creatinine <=1.5mg/dL 10)Women of childbearing potential must have a negative pregnancy test within 7days prior to enrollment. Patients who do have intention that uses effective contraception method until 6 months after administering investigational drug. 11)Patient is willing or able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1)Serious coexisting illness as follows. a. Active double cancer(s) b. CNS metastasis c. Uncontrollable infectious disease d. Uncontrollable pleural effusion, ascites, or cardiac effusion e. Ileus, interstitial pneumonia,renal failure, hepatic failure or cerebrovascular disorder f. Uncontrolled diabetic g. Uncontrolled hypertension h. Cardiac infarction, serious angina or New York Heart Association Class III or IV within 6 months prior to the registration i Gastrointestinal bleeding j Positive HBs antigen, HCV antibody or HIV antibody k. Need immunosuppressive therapy l. Uncontrolled mental disease or the psychotic manifestation 2)Receive the treatment as follows. a.Major surgery therapy within 4 weeks prior to enrollment. b.Chemotherapy within 3 weeks prior to enrollment. c. Wide field radiotherapy 4 weeks prior to enrollment or local radiotherapy 2 weeks prior to enrollment. d.Other investigational drugs within 4 weeks prior to enrollment. 3)Prior treatment with TAS-102 or Nintedanib 4)Unrecovered AEs related to prior treatment are Grade >= 2 according to CTCAE. 5)Blood transfusion or G-CSF within 14 days prior to enrollment. 6)Serious renal failure or proteinuria >= 2+ within 7days prior to enrollment. 7)Thromboembolic event or serious Pulmonary complaints within one year 8)Uncomplete cure wound or traumatic fracture 9)Tendency to hemorrhages or taking antithrombotic medication 10) Women during pregnancy or lactation , 11) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival:OS PFS Objective response rate:ORR Disease control rate:DCR Adverse event:AE PK,PD | — |
Primary
| Measure | Time frame |
|---|---|
| 16 weeks progression free survival rate ( 16W PFS rate) | — |
Countries
Japan
Contacts
Public ContactYasutoshi Kuboki
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed