Colon cancer
Conditions
Interventions
HAIC combination therapy group:Fruquintinib combined with hepatic artery infusion chemotherapy
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged over 18 at the time of signing the informed consent, pathologically or cytologically diagnosed colorectal cancer, with liver metastases and cannot be surgically removed; 2.Failed of second-line or second-line standard chemotherapy (FOLFOX, FOLFIRI, XELOX) ± targeted therapy; 3.Eastern Cooperative Oncology Group (ECOG) physical status score = 1.5 x 10^9/L, platelets >=75 x 10^9/L, hemoglobin >= 90 g/L; (2)Serum creatinine =50 mL/min/1.73 m^2; (3)AST and ALT = 30 g/L; (4)International normalized ratio (INR) <= 1.5 or prothrombin time <= 1.5 times ULN, activated partial thromboplastin time (aPTT) <= 1.5 times ULN; 6.At least one measurable liver target lesion defined by RECIST v1.1; 7.The expected survival period is longer than 6 months; 8.No serious cardiopulmonary disease, with sufficient lung and heart function to tolerate hepatic artery infusion chemotherapy; 9.Fully understand this study, volunteer to participate, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Active gastrointestinal bleeding occurred within 6 months; 3.Poorly controlled hypertension after drug treatment (defined as: systolic blood pressure> 160 mmHg and/or diastolic blood pressure> 100 mmHg); 4.There is a severe hypersensitivity reaction to furquintinib or chemotherapy drugs (fluorouracil, oxaliplatin, tetrahydrofolate) or contrast media used in hepatic artery infusion; 5.Any Chinese herbal medicine or proprietary Chinese medicine with anti-cancer activity approved by the National Medical Products Administration (NMPA) within 14 days before the first administration of the study drug; 6.There are pleural effusions, pericardial effusions, and abdominal effusions that cannot be controlled and require drainage intervention; 7.With intestinal obstruction, perforation, or at the same time with bone metastasis and central nervous system metastasis; 8.Combined with primary malignant tumors of other systems except colorectal cancer; 9.Combined with acute infection; 10.Any unstable conditions or situations that may endanger the safety of the patient and his/her compliance with the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective disease response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression;Overall survival time;Disease Control Rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactYin Xin
Zhongshan Hospital, Fudan University
Outcome results
None listed