Advanced metastatic colorectal cancer
Conditions
Interventions
Group A:fruquintinib combined with capecitabine and irinotecan hydrochloride liposome
Group B:bewacrzunhap combined with irinotecan hydrochloride liposome and chemotherapy capecitabine
Single-arm group:fruquintinib combined with capecitabine and irinotecan hydrochloride liposome
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participated in this study and signed informed consent; 2. Age: 18-75 years old (including 18 and 75 years old), male or female; 3. Histologically or cytologically confirmed patients with unresectable advanced colorectal cancer; 4. Patients who had failed previous standard first-line therapy or were intolerant to first-line therapy (those who had received adjuvant or neoadjuvant therapy of one regimen and had progressed or relapsed within 6 months of the end of treatment were eligible); 5.ECOG PS: 0-1; 6.At least one measurable lesion (RECIST version 1.1); 7. The function of major organs and bone marrow is basically normal (no blood components and cell growth factors have been used within 14 days before enrollment) : 1) Blood routine: neutrophil >= 1.5x 10^9/L, platelet >= 90x 10^9/L, hemoglobin >= 80g/L; 2) International normalized ratio (INR) = 50mL/min; 8. Women of childbearing age must have a negative serum pregnancy test within 14 days before treatment; Eligible patients (men and women) who are fertile must agree to use a reliable method of contraception (hormonal or barrier methods or abstinence, etc.) with their partner during the trial and for at least 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Major surgery or severe trauma within 4 weeks before the first use of the study drug; 2. Current immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ day of prednisone or other therapeutic hormones) and continued use within 2 weeks before enrollment; 3. Previous treatment with irinotecan; 4. Received live attenuated vaccine within 4 weeks before the first use of the study drug; 5. Previous treatment with anti-vascular small molecule targeted drugs; 6. Have any active autoimmune diseases or have a history of autoimmune diseases (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis; Subjects with vitiligo or childhood asthma in complete remission without any intervention in adulthood were included; Subjects with asthma requiring medical intervention with bronchodilators were excluded); 7. Other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix; 8. Congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA>= 104 copies /ml or >2000 IU/ml; Hepatitis C: HCV antibody positive); 9. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA2 or above heart failure; (2) unstable angina; (3) had a myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 10. Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); 11. Severe active or uncontrolled infection (>= CTCAE grade 2 infection); 12. Urine routine showed urinary protein >= 2+, and 24-hour urinary protein >1.0g; 13. Known hereditary or acquired bleeding and thrombophilia (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.) or receiving thrombolytic or anticoagulant therapy; 14. The patient currently has gastrointestinal diseases such as active ulcers of the stomach and duodenum, ulcerative colitis, or active bleeding in the unresected tumor, or other conditions that may cause gastrointestinal bleeding, perforation, and intestinal obstruction as determined by the researcher; 15. Patients with significant evidence or history of bleeding tendency within 3 months before enrollment (bleeding >30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood >5 mL within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 16. Pregnant women (positive pregnancy test before medication) or breastfeeding; 17. Patients with allergies to study drugs or exciplents; 18. The subject has other conditions that, in the investigator's judgment, may affect the results of the study or cause the study to be stopped, such as substance abuse, serious illness (including psychiatric disorders such as seizures), and other medical, psychological, or social conditions that may compromise patient safety and compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;ORR;OS;DCR; | — |
Countries
China
Contacts
Public ContactXianglin Yuan
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed