colorectal cancer
Conditions
Interventions
1:TAS102+Anlotinib
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Male or female patients aged 18 and above; 2) Colorectal cancer patients diagnosed by histology or cytology; 3) Patients with unresectable metastatic colorectal cancer (T1-4N0-2M1); 4) According to the RECIST 1.1 criteria for evaluating the efficacy of solid tumors, at least one measurable lesion should be accurately measured with a diameter of = 1cm through enhanced magnetic resonance imaging (MRI) or computed tomography (CT); 5) Patients who have previously received standard chemotherapy containing fluorouracil, oxaliplatin, and irinotecan but have failed or are intolerant can receive treatment with bevacizumab, cetuximab, pertuzumab, ramolizumab, and abercept; 6) ECOG PS score: 0-1 points; 7) Expected survival period exceeding 3 months; 8) Having sufficient organ and bone marrow function (within 7 days before treatment) (1) The standard for blood routine examination must comply with: Hemoglobin content (HB) = 8.0 g/dL (no blood transfusion within 28 days); White blood cells (WBC) = 3.0 × 10 ^ 9/L; Absolute neutrophil count (ANC) = 1.5 × 10 ^ 9/L; Platelet count (PLT) = 75 × 10 ^ 9/L. (2) Biochemical examination must meet the following standards: Total serum bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); ALT and AST = 2.5XULN (if there is liver metastasis, ALT and AST = 5XULN); Cr = 1.5XULN or creatinine clearance rate (CCr) = 60ml/min; (Cockcroft Fault formula) 9) Women of childbearing age should take appropriate contraceptive measures and avoid breastfeeding three months after screening and cessation of research and treatment. Before starting administration, if the pregnancy test is negative or there is no risk of pregnancy: for males, they must agree to use appropriate methods of contraception or undergo surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 10) The patient voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) Previously received treatment with trafluorouracil and piperazine tablets, as well as amlotinib hydrochloride, furoquinib, regorafenib, and apatinib; 2) Participated in other drug clinical trials or received other treatments within the first 4 weeks of enrollment, such as radiotherapy, chemotherapy, anti-tumor traditional Chinese medicine, intervention, targeted or immunotherapy; 3) Unresolved toxic reactions caused by any previous treatment that are higher than level 1 of CTCAE, excluding hair loss or similar toxicity that is considered clinically insignificant or puts participants at greater risk; 4) There are multiple factors that affect the use of therapeutic drugs, such as: a) Unable to swallow; b) Chronic diarrhea or intestinal obstruction, significantly affecting medication administration and absorption; c) Known to have a history of severe allergies to any of the drug components in this study; 5) Patients with the following bleeding risks: a) Within the 4 weeks prior to enrollment, patients with any bleeding or bleeding events, NCI-CTC AE = grade 3, with unhealed wounds, ulcers, or fractures; b) Have experienced arterial/venous bleeding events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism; c) A history of gastrointestinal perforation and/or fistula within 6 months, with a tendency towards gastrointestinal bleeding; 6) Received significant surgical treatment, open biopsy, or obvious traumatic injury within 28 days prior to enrollment; 7) Having a history of immunodeficiency, including HIV testing positive or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation; 8) Known to have symptomatic central nervous system metastasis and/or cancerous meningitis; 9) History of other primary malignant tumors, except for: 1) Malignant tumors that have completely relieved for at least 2 years prior to enrollment and do not require additional treatment during the study period; 2) Non melanoma skin cancer or malignant freckle like nevi that have been adequately treated and have no evidence of disease recurrence; 3) In situ cancer with sufficient treatment and no evidence of disease recurrence; 10) Patients with severe heart, lung, and kidney dysfunction or any severe and/or uncontrolled disease, including: Patients with poor blood pressure control after using antihypertensive drugs (systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg); Suffering from grade II or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc, male = 450ms; female = 470ms, congestive heart failure (NYHA classification); Active or uncontrolled severe infection (NCI-CTC AE grade = 2 infection); Interstitial lung disease; Liver diseases such as cirrhosis, active or chronic hepatitis (hepatitis virus load>1000IU/ml) that require antiviral treatment; Renal failure requires hemodialysis or peritoneal dialysis; Poor control of diabetes (FBG>10 mmol/L); Urine routine indicates urine protein =++, and it is confirmed that 24-hour urine protein quantification>1.0 g; Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN) and bleeding tendency, or undergoing thrombolysis or anticoagulation treatment (note: small doses of low molecular weight heparin (daily dose for adults is 6000-12000 U) or low-dose aspirin (daily dose = 100 mg) are allowed for preventive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR; DCR;OS;Drug safety; | — |
Countries
China
Contacts
Public Contactliu tianshu
Zhongshan Hospital, Fudan University
Outcome results
None listed