Colorectal Cancer Liver Metastasis
Conditions
Interventions
Experimental group:HAIC Treatment: In this study, HAIC employs the FOLFIRI regimen, where Levofolinic Acid is mixed and administered concurrently with 5-FU. HAIC treatment is alternated with intraveno
Control group:Fruquintinib:5 mg orally, once daily for 21 days, followed by 7 days off in 28-day cycles
Sponsors
Zhongshan hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all the following eligibility criteria to qualify for this trial: 1.Age between 18 and 75 years, with no gender restrictions; 2.Histologically and/or cytologically confirmed colorectal cancer with incurable liver metastases that cannot be surgically removed; 3.At least one measurable lesion as defined by RECIST version 1.1; 4.ECOG performance status: 0-1 points and expected survival >3 months; 5.Has received first-line and second-line systemic antitumor therapy for metastatic colorectal cancer (mCRC), which may include fluoropyrimidines, oxaliplatin, and irinotecan, such as XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; may be combined or not combined with targeted therapies, such as cetuximab, bevacizumab); and disease progression after the second-line therapy; 6.Liver function classified as Child-Pugh Class A; 7.Fully understands this study and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible to participate in this study: 1. Absolute neutrophil count (ANC) 2.5 times the upper limit of normal (ULN); 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >5 times ULN; 4. Serum creatinine >1.5 times the upper limit of normal (ULN), or creatinine clearance 1.5 times ULN (based on the normal values of the clinical trial research center); 6. Albumin =1 year before screening should also be excluded unless proof can be provided that appropriate treatment has been completed; 13. Presence of bone metastasis, peritoneal metastasis, ovarian metastasis, brain metastasis, or leptomeningeal metastasis; 14. Clinically significant pleural effusion, pericardial effusion, or ascites requiring multiple drainages within 2 weeks before the first administration of study medication; 15. Clinically detectable second primary malignant tumors at the time of enrollment, or other malignant tumors that occurred within the past 5 years (except for adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ); 16. Poorly controlled diabetes or electrolyte disorders despite standard medical treatment; 17. Known history of human immunodeficiency virus infection; 18. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA higher than 500 IU/mL, and patients with positive hepatitis C virus (HCV) RNA should be excluded; inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA 140mmHg or diastolic blood pressure >90mmHg after monotherapy; 22. Current duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; or history of intestinal perforation, fistula, and those who have not recovered after surgical treatment; 23. History of arterial thrombosis or deep vein thrombosis within 6 months before enrollment, or evidence or history of bleeding tendency within 2 months before enrollment, regardless of severity; 24. History of stroke or transient ischemic attack within the last 12 months; 25. Skin wounds,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS;Differences in the efficacy of Hepatic Artery Infusion Chemotherapy (HAIC) for Massive versus Diffuse Metastatic Liver Cancer;The correlation between the dynamic changes of serum proteomics in patients and the efficacy of Hepatic Artery Infusion Chemotherapy (HAIC); | — |
Countries
China
Contacts
Public ContactTianshu Liu
Zhongshan hospital, Fudan University
Outcome results
None listed