Advanced colorectal cancer
Conditions
Interventions
Anrotinib 10mg group:Anrotinib hydrochloride 10mg
Anrotinib 8mg group:Anrotinib hydrochloride 8mg
Sponsors
Guangxi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged 18 years and above; 2. Pathologically diagnosed patients with advanced colorectal and rectal adenocarcinoma (all other histological types excluded); 3. Previously received first-line standard chemotherapy (fluorouracil, irinotecan and oxaliplatin must be used in the standard chemotherapy regimen), and the treatment failed or was not tolerated.Definition of "treatment failure" : (1) clear imaging or clinical evidence of disease progression during the treatment process or within 3 months after the last treatment; (2) unable to tolerate chemotherapy adverse events out of the standard treatment by CTCAE 4.0 standards, their level of intolerance of hematology serious adverse events to reach more than IV degree (platelets reduced to III degree above) or non hematologic adverse events serious level III degree or above, and the researchers determine the subjects were still unable to repeat the original regimen for tolerance. Note: 1) each line of treatment for progressive disease includes one or more drugs that have been used for more than 1 cycle or longer. 2) if oxaliplatin-containing adjuvant therapy is carried out in the early stage, at least 9 courses of FOLFOX (2-week program) or 6 or more courses of CapeOX (3-week program) should be accepted according to the course of treatment; Or at least 4.5 months of adjuvant treatment on a time-based basis; Or the cumulative use of oxaliplatin 750mg/m2. If disease progression occurs during or less than 6 months after completion of the adjuvant treatment, the adjuvant treatment is considered to be the first-line treatment for the progressive disease. 3) the allowed early treatment is chemotherapy combined with monoclonal agents (bevacizumab, cetuximab, parnizumab, and apexip). 4. According to RECIST 1.1 criteria, the patient had at least one target lesion with a measurable diameter (tumor lesion CT scan length diameter > 10 mm, lymph node lesion CT scan short diameter > 15 mm, scanning layer thickness > 5 mm; And has not received local treatment); 5.ECOG physical condition score: 0-2; 6. The expected survival time is 3 months; 7. The main organs have good functions, that is, the relevant examination indexes within the first 14 days of random inspection meet the following requirements: A) blood routine examination: I. hemoglobin > 90 g/L (no transfusion within 14 days); II. Neutrophil count > 1.5 X 10^9/L; III. Platelet count > 100 X 10^9/L; B) biochemical examination: I. total bilirubin 1.5 ULN (upper limit of normal value); II. ALT or AST less than 2 ULN; ALT or AST < 5 ULN in the case of liver metastasis; III. Endogenous creatinine clearance 60 ml/min (Cockcroft-Gault formula); cardiac doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) 50%. 8. The damage caused by the subject receiving other treatments has been recovered, and the interval between receiving nitroso or mitomycin and signing the informed consent is no less than 6 weeks; To receive other cytotoxic drugs, radiotherapy or surgery for more than 4 weeks, and the wound has been completely healed; 9. Sign the informed consent; 10. The compliance was good, and the family members agreed to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent malignancy with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. Patients previously treated with small-molecule tyrosine kinase inhibitors of VEGFR (such as famitinib, sorafenib, sunitinib and regofeni, etc.); 3. Participated in clinical trials of other drugs within four weeks; 4. Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 5. With a history of bleeding, any bleeding event with grade 3 or above in CTCAE4.0 occurred within 4 weeks before screening; 6. Patients with known CNS metastasis or a history of CNS metastasis were screened. For patients with clinical suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before randomization to exclude central nervous system metastasis. 7. Patients with hypertension who cannot obtain good control after single antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Having a history of unstable angina pectoris; Patients newly diagnosed with angina within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmia (including QTcF: male 450 ms, female 470 ms) requires long-term use of anti-arrhythmia drugs and New York heart association grade II cardiac dysfunction; 8. Urine routine test indicated urine protein ++ and confirmed the 24-hour urine protein quantitative > 1.0g; 9. Long-term unhealed wounds or incomplete fractures; 10. Imaging studies showed that the tumor had invaded important blood vessels, or the researchers judged that the patient's tumor had a very high possibility to invade important blood vessels during treatment, resulting in fatal massive bleeding; 11. Patients with abnormal coagulation function and bleeding tendency (the INR must be within the normal range in the absence of anticoagulant 14 days before randomization); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; The use of low-dose warfarin (1 mg oral, once daily) or low-dose aspirin (no more than 100 mg daily) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) is no more than 1.5; 12. The events of hyperactive/venous thrombosis occurred in the previous year were screened, such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by venous catheterization in the early stage of chemotherapy, which was determined to have been cured by the researcher) and pulmonary embolism, etc.; 13. For female subjects: surgical sterilization, post-menopausal patients, or consent to use a medically approved contraceptive during the study treatment period and within 6 months after the study treatment period; The serum or urine pregnancy test must be negative and non-lactation within 7 days prior to study enrollment. Male subjects: shall be patients undergoing surgical sterilization, or who have agreed to use a medically approved contraceptive during and within 6 months after the study treatment period. 14. Abnormal thyroid function exists in the past, and thyroid function cannot be maintained within the normal range even under the condition of drug treatment; 15. Has a history of psychotropic substance abuse and cannot quit or has a mental disorder; 16. Pleural effusion or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactYuMei Zhang
Guangxi Medical University Affiliated Tumor Hospital
Outcome results
None listed