colorectal cancer
Conditions
Interventions
Group of colorectal cancer:Regorafenib plus TAS-102
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. All subjects are required to sign an informed consent form before the start of the study; 2. Be at least 18 years old, male or female; 3. ECOG PS score of 0 to 1 and life expectancy of more than 3 months; 4. Patients with a diagnosis of metastatic or recurrent colorectal cancer confirmed by pathological histology or cytology; 5. Subjects have already received standard two-line therapy followed by treatment failure or intolerance (including chemotherapy containing fluorouracil, oxaliplatin, and irinotecan, combined with bevacizumab and or cetuximab-targeted therapy); 6. Have measurable lesions (according to RECIST 1.1); For lesions previously treated with radiotherapy, the lesion may be included as a measurable lesion only if the lesion exhibits definite disease progression after radiotherapy and the lesion is not the only measurable lesion in the patient; 7. Adequate bone marrow, renal and liver function (time: within 7 days prior to the start of study treatment); 8. Amylase and lipase = 1.5 times ULN; Urine routine showing urine protein < 1+ or 24-hour urine protein quantification showing urine protein < 1 gram; 9. International normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is on anticoagulation therapy, as long as the PT is within the range established by the anticoagulant; 10. Female/male patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injection birth control medication or intrauterine device, during the study and for 90 days after study completion. All female patients will be considered fertile unless they have undergone spontaneous menopause, artificial menopause, or sterilization (e.g. hysterectomy, bilateral adnexectomy, radiation ovarian irradiation, etc.
Exclusion criteria
Exclusion criteria: 1. Previously treated with small molecule multi-targeted anti-angiogenic targeted drugs such as regorafenib, furoquitinib, apatinib and TAS-102; 2. Other malignancies within the past 5 years that require aggressive treatment, except for basal cell carcinoma of the skin post radical surgery or carcinoma in situ of the cervix; 3. Active central nervous system (CNS) metastases and/or carcinomatous meningitis; 4. History or presence of digestive tract diseases, including active gastric/duodenal ulcer or ulcerative colitis, or active hemorrhage of an unresected gastrointestinal tumor, or an evaluation by investigators of having any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation; 5. History or presence of serious hemorrhage ( > 30 mL within 3 months), hemoptysis (> 5 mL fresh blood within 4 weeks) or a thromboembolic event (including transient ischemic attack) within 12 months; 6. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class >= 2; ventricular arrhythmia requiring pharmacologic treatment; left ventricular ejection fraction (LVEF) = 140 mmHg or diastolic blood pressure >= 90mmHg; 8. Any clinically significant active infection, including but not limited to human immunodeficiency virus (HIV) infection, known history of significant liver disease, including but not limited to known hepatitis B virus (HBV) infection and positive HBV DNA (>= 1 x 10^4 /mL); known hepatitis C virus infection (HCV) and positive HCV RNA (>=1 x 10^3 /mL), the or cirrhosis, etc.; 9. Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for hair loss); 10. Receive investigational treatment in another clinical study within the 4 weeks prior to enrolment; 11. Any other disease, metabolic abnormality, physical examination abnormality, abnormal laboratory result, or any other condition that investigators suspect may prohibit use of the investigational product, affect interpretation of study or put the patient at high risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;disease control rate ;overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJing Hao
Qilu Hospital of Shandong University
Outcome results
None listed