Colorectal Cancer with Liver Metastasis
Conditions
Interventions
Treatment Group:Fruquintinib combined with continuous hepatic arterial infusion of raltitrexed chemotherapy.
Sponsors
Clinical Oncology School of Fujian Medical University,Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Ages between 18 and 75 years old, ECOG score: 0 to 1 points, with an expected survival time of =3 months;· 2.Diagnosed with colorectal adenocarcinoma through pathological histology or cytology; 3.At least one measurable intrahepatic lesion (according to RECIST 1.1 criteria) detectable by CT, MRI, or PET/CT; 4.Patients who have failed two or more prior treatments; 5.Major organs and bone marrow function are essentially normal: 6.Meet the indications and basic requirements for chemotherapy, including essentially normal peripheral blood counts, no significant abnormalities in heart, liver, and kidney functions, essentially normal ECG, and no unhealed wounds on the body; Laboratory indicators must meet the following requirements: Peripheral blood counts: White blood cells (WBC) =3.5×10^9/L, Platelets (PLT) =80×10^9/L, Hemoglobin (Hb) =80g/L. Renal function: Serum creatinine (Cr) =2.0×upper normal limit (UNL), Blood urea nitrogen (BUN) =2.5×UNL. Liver function: Serum bilirubin (IBIL) =2.5×UNL, Serum transaminases (ALT/AST) =2.5×UNL; 7.For subjects who have previously used other chemotherapy drugs, at least a 4-week clearance period is required before entering this trial; 8.Fully understand this study, voluntarily participate, have good compliance, can cooperate with trial observations, and have signed the informed consent form. 9.Patients with reproductive capacity, male or female, voluntarily use effective contraceptive methods during the study period and for 6 months after the last study drug administration, such as dual barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to have reproductive capacity unless the female patient has natural menopause, artificial menopause, or has undergone surgical sterilization (such as hysterectomy, bilateral adnexectomy, or radioactive ovarian irradiation, etc.).
Exclusion criteria
Exclusion criteria: 1.Patients who have previously received treatment with fruquintinib, raltitrexed, or have undergone liver intervention therapy; 2.Patients with untreated central nervous system metastasis (those who have previously received systemic, radical treatment for brain or meningeal metastasis (radiation therapy or surgery), if imaging confirms stability for at least 1 month, and have stopped systemic steroid treatment (dose >10mg/day prednisone or other equivalent efficacy steroids) for more than 2 weeks, and have no clinical symptoms can be included); 3.Factors affecting drug administration, absorption, distribution, metabolism, and excretion, patients with uncontrollable epileptic seizures, central nervous system disorders, or loss of self-awareness due to mental illness; 4.Second primary malignant tumors; 5.Any surgery or invasive treatment or procedure within 4 weeks prior to enrollment (except for venous catheterization, puncture drainage, etc.); 6.Clinically significant electrolyte abnormalities as judged by the investigator; 7.Patients currently have uncontrolled hypertension, defined as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 8.Patients allergic to the treatment drugs; 9.Patients with hypersensitivity, those with autoimmune diseases; 10.Patients currently have active ulcers of the stomach and duodenum, ulcerative colitis, and other gastrointestinal diseases, or unresected tumors with active bleeding, or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation; 11.Patients with significant evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding >30mL within 3 months, with vomiting blood, melena, bloody stool), hemoptysis (>5mL of fresh blood within 4 weeks), or thromboembolic events within 12 months (including stroke events and/or transient ischemic attacks); 12.Significant clinically relevant cardiovascular diseases, including but not limited to acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina, or coronary artery bypass grafting; congestive heart failure with New York Heart Association (NYHA) classification >2; ventricular arrhythmias requiring drug treatment; electrocardiogram (ECG) showing QTc interval =480 milliseconds; 13.Patients participating in other clinical trials at the same time; 14.Pregnant (positive pregnancy test before drug use) or breastfeeding women; 15.As judged by the investigator, patients have other factors that may affect the results of the study or cause the study to be terminated prematurely, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Relief time;The surgical conversion rate of liver metastases;The safety of treatment; | — |
Countries
China
Contacts
Public ContactWeiGao
Clinical Oncology School of Fujian Medical University,Fujian Cancer Hospital
Outcome results
None listed