Colorectal cancer
Conditions
Interventions
Experimental group:Stage I: fuquinitinib
Stage 2: fuquinitinib combined with chemotherapy or PD-1
Sponsors
Zibo Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the study, sign the informed consent, and have good compliance; 2. At least 18 years old; 3. Metastatic colorectal cancer confirmed histologically and/or cytologically; Tumor PR\CR\SD was evaluated after 8 cycles of second-line standard therapy, which must include fluorouracil (5-fluorouracil or capecitabine or Tigorgone), oxaliplatin, and irinotecan; Use of fuquinitinib or other small molecule TKI targeting drugs. 4. The patient must have at least one measurable lesion (RECIST 1.1); 5.ECOG physical condition 0-1 score; 6. Expected survival =12 weeks; 7. Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value =1.5×109/L, platelets =100×109/L, hemoglobin concentration =9g/dL); 2) Liver function test (aspartate aminotransferase and glutamic aminotransferase =2.5×ULN, bilirubin =1.5×ULN; In case of liver metastasis, AST and ALT=5×ULN); 3) Renal function (serum creatinine =1.5×ULN, or creatinine clearance (CCr)=60ml/min); 4) Coagulation, International standardized ratio (INR) =1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) =1.5×ULN; 5) Thyroid function, thyroid stimulating hormone (TSH) = the upper limit of normal (ULN); 8.Women of childbearing age must have had a negative serum pregnancy test within 14 days prior to treatment and be willing to use a medically approved effective contraceptive (e.g., IUD, contraceptive or condom) during the study period and within 3 months after the last time they took the study drug; For male subjects whose partner is a woman of reproductive age, surgical sterilization is required or an effective contraceptive method is recommended during the study period and within 3 months after the last study dosing.
Exclusion criteria
Exclusion criteria: 1. Received the following treatments within 4 weeks prior to treatment: radiation therapy for tumors, surgery, other investigational drugs; 2. Previously received anti-vascular small-molecule targeted drug therapy, such as fuquintinib; 3. Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable); 4. Severe infection (such as intravenous infusion of antibiotics, antifungals, or antiviral drugs) within 4 weeks prior to treatment, or unexplained fever > 38.5 ° C during screening/first administration; 5. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 6. Obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months prior to treatment (bleeding > 30 mL within 3 months, hematemesis, black stool, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), etc. Or treatment of arterial/venous thrombosis events within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin =300 mg/day or clopidogrel =75 mg/day) is required; 7. Active heart disease, including myocardial infarction, severe/unstable angina in the 6 months prior to treatment. Left ventricular ejection fraction 1×104 copies /mL or >2000 IU/ml) must be excluded for known hepatitis B virus (HBV) carriers; 3) Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis]; 11. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or that would affect the interpretation of the study results or place the patient at high risk; 12.Urine routine indicated urine protein =2+, and 24-hour urine protein quantity >1.0g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of remission;1 year OS rate;progression free survival;Time to Failure; | — |
Countries
China
Contacts
Public ContactYuzhong Cui
Zibo Municipal Hospital
Outcome results
None listed