Colorectal cancer
Conditions
Interventions
Experimental group:Fruquintinib+bemarituzumab
Sponsors
Taian Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, no gender restriction; 2. Histologically confirmed advanced metastatic colorectal cancer; 3. Pathologically confimed MSS/pMMR; 4. At least one measurable lesion according to RECIST v1.1 criteria; 5. Previously received >=2 lines of standard chemotherapy (including oxaplatin, irinotecan, fluoropyrimidines, or regorafenib) plus targeted therapy (such as bevacizumab or cetuxiab); 6. ECOG PS: 0-1; 7. Adequate organ function: Hematology: Hemoglobin >=80g/L; Neutrophi count >=1.5×10^9/L; White blood cell count >=3.5×10^9/L; Platelets >=100×10^tic function: Serum total bilirubin =60 mL/min; Cardiac function: New York Heartssociation (NYHA) class =50%. 8. Expected survival >=3 months; 9. Women of childbearing potential mused reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and be willing to use appropriate contraception during the trial and months after the last administration of the trial drug. For men, must agree to use appropriate contraception during the trial and for 6 months after the last administration of the tral drug; 10. Study participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Allergy to any investigational drug or its excipients, history of severe allergy, or contraindications to estigational drug; 2. Uncontrolled cardiovascular or cerebrovascular events, such as: a. NYHA Class II or higher heart failure; b. unstable angina. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; e. cerebral hemorrhage and rebral infarction (excluding asymptomatic lacunar infarction requiring no treatment); f. severe cardiovascular or cerebrovascular events within 12 months; g. uncontrolled hyptension, i.e., systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg after monotherapy; h. history of arteriahrombosis or deep vein thrombosis within 6 months prior to enrollment, or patients with evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of ; i. history of stroke or transient ischemic attack within 12 months prior to enrollment; 3. Received systemic treatment with Traditional Chinese Medicine (TCM) or drugs with immutory effects (including thymosin, interferon, interleukin, excluding local use for controlling ascites) indicated for colorectal cancer within 2 weeks prior to thfirst dose; 4. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute pulmonary disease, or uncontrolled systemic disease (including but not limited to dtes mellitus, hypertension); 5. History of active immunodeficiency or autoimmune disease, including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, oory of organ transplantation or autoimmune disease; 6. Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection, eatients with a history of active tuberculosis infection =1 year prior to screening should also be excluded unless proof of completed appropriate treatment can be provided; 7. Presence of brain metastas leptomeningeal metastases; 8. Clinically significant pleural effusion, pericardial effusion, or ascites requiring multiple drainage procedures within 2 weeks to the first dose of the study drug; 9. Presence of a clinically detectable second primary malignancy at enrollment, or history of other malignancies within the past 5 years (excludintely treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); 10. Underwent any major surgery <=28 days prior to the first dose of th study drug; 11. Previous allogeneic stem cell transplantation or organ transplantation; 12. Currently has gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, or intestinal obstruction, or other conditions determined by the inv potentially cause gastrointestinal bleeding or perforation; or has a history of intestinal perforation or fistula that has not been cured after surgical treatment; 13. Received a live vacine within 4 weeks (inclusive) prior to the first administration of the study drug; seasonal injectable influenza vaccines are usually inactivated vaccines and are therefore permitted; intranasal vacciive vaccines and are therefore not permitted; 14. The investigator determines that the study participant has other factors that may lead to forced early termination of the study, such as other serious (including psychiatric diseases) requiring concomitant treatment, severe laboratory abnormalities, or factors such as family or social issues
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Duration of response;Disease control rate;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactQi Huanpeng
Taian Central Hospital
Outcome results
None listed