Colorectal cancer
Conditions
Interventions
Experimental group:Hepatic arterial infusion chemotherapy
Experimental group:Regorafenib
Experimental group:Intravenous infusion PD-1 inhibitors
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically or cytologically confirmed colorectal cancer, with liver metastases, and unable to undergo surgical resection. Aged over 18 years old when signing the informed consent form. 2. Second-line or second-line targeted therapy failure with standard chemotherapy (FOLFOX, FOLFIRI, XELOX) +/- macromolecule targeted therapy; 3. Eastern Cooperative Oncology Group (ECOG) physical status score = 1.5*10^9/L, platelets >= 75*10^9/L, hemoglobin >= 90 g/L ; Serum creatinine = 50 mL/min/1.73 m2; AST and ALT =30 g/L; 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 1 measurable target lesion in the liver as defined by mRECIST; 7. Expected survival time greater than 6 months; 8. No serious cardiopulmonary disease, with sufficient lung and heart function to tolerate hepatic arterial infusion chemotherapy; 9. Fully understand this study, participate voluntarily, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Active gastrointestinal bleeding occurs within half a year; 3. Uncontrolled hypertension after drug therapy (defined as: systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg); 4. Severe hypersensitivity reactions to regorafenib or chemotherapeutic drugs (fluorouracil, oxaliplatin, tetrahydrofolic acid) or contrast agents used in hepatic arterial perfusion; 5. Have used any Chinese herbal medicines or proprietary Chinese medicines with anticancer activity approved by the National Medical Products Administration (NMPA) within 14 days before the first administration of the study drug; 6. There are uncontrollable pleural effusion, pericardial effusion, and ascites that require drainage intervention; 7. Combined with intestinal obstruction, perforation, or combined with bone metastasis and central nervous system metastasis; 8. Combined with other systemic primary malignant tumors except colorectal cancer; 9. Combined with acute infection; 10. Any unstable condition or condition that may jeopardize the safety of the patient and his/her compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS);hepatic Progression Free Survival (hPFS);Disease Control Rate (DCR);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactGuowen Yin, Liangjun Zhu
Jiangsu Cancer Hospital
Outcome results
None listed