Advanced colorectal cancer
Conditions
Interventions
Experimental Group 1:Bevacizumab: 5 mg/kg, intravenous infusion, d1
Irinotecan: 150-180mg/m^2, intravenous infusion, day 1
Oxaliplatin: 85mg/m^2, IV, d1, intravenous infusion for 2-6 hours
Experimental Group 2: Bevacizumab: 5 mg/kg, intravenous infusion, d1
Irinotecan liposomes (II): 60mg/m^2 (calculated as free base), intravenous infusion for at least 90 minutes, d1
Oxaliplatin: 85mg/m
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75, of either gender; 2. Patients with colorectal adenocarcinoma confirmed by pathology/cytology (all other histological types are excluded); 3. Have previously received at least two lines of standard treatment (including regimens containing oxaliplatin/irinotecan, except for those who have used a combination regimen of oxaliplatin and irinotecan), with radiographic evidence of disease progression; 4. According to the RECIST 1.1 criteria, the patient must have at least one measurable target lesion; 5. ECOG score: 0-1 points; 6. Expected survival duration >=3 months; 7. The main organs function well, meaning that the relevant examination indicators within 14 days before randomization meet the following requirements: (1) Blood routine examination (no blood transfusion or use of leukocyte-increasing or platelet-increasing drugs within 14 days before screening): Hemoglobin > 90 g/L; Neutrophil count > 1.5×10^9/L; Platelet count > 75×10^9/L; (2) Biochemical examination: Total bilirubin = 50%. 8. The damage caused by the subject's receiving other treatments has been restored; 9. The subjects voluntarily joined this study, signed the informed consent form, exhibited good compliance, and cooperated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients who have suffered from other malignant tumors within the past 5 years (excluding cured carcinoma in situ and cutaneous basal cell carcinoma); 2. Known allergy to the study drug and related components; 3. Participated in other drug clinical trials within four weeks before enrollment; 4. Patients with any imaging-confirmed bone metastatic lesions; 5. History of active gastric/duodenal ulcer or ulcerative colitis within the previous 6 months; active bleeding, perforation, or fistula of unresected gastrointestinal tumors; or any other condition that, in the investigator's judgment, may lead to gastrointestinal bleeding or perforation; 6. Presence of intestinal obstruction or symptoms and signs of intestinal obstruction, or previous intestinal stent implantation and the intestinal stent remains unremoved up to the screening period; 7. Severe diarrhea (according to the NCI-CTCAE 6.0 criteria, Grade 2 or higher diarrhea: an increase in stool frequency of >=4 times per day compared to baseline; moderate to severe increase in stoma discharge; limitation in activities of daily living) 8. Known peripheral neuropathy (CTCAE >= Grade 3); 9. History of bleeding, with any severe bleeding event reaching CTCAE 6.0 Grade 3 or above occurring within 4 weeks prior to screening; 10. Patients with known or history of central nervous system metastasis before screening, except for those without clinical symptoms. For patients clinically suspected of having central nervous system metastasis, an enhanced CT or enhanced magnetic resonance imaging (MRI) examination must be performed within 28 days before randomization to exclude central nervous system metastasis; 11. Patients with hypertension who cannot achieve good control with single antihypertensive drug therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); patients with a history of unstable angina pectoris; patients newly diagnosed with angina pectoris within 3 months before screening or who have experienced myocardial infarction within 6 months before screening; patients with arrhythmias (including QTcF: >=450 ms for males and >=470 ms for females) requiring long-term use of antiarrhythmic drugs and New York Heart Association functional classification of >=II heart dysfunction; 12. Urine routine test indicates urinary protein >=++ and confirmed 24-hour urinary protein quantitation >1.0 g; 13. Long-term unhealed wounds or incomplete healing of fractures; 14. Imaging studies show that the tumor has invaded the surrounding area of important blood vessels, or the researcher judges that there is a high possibility that the patient's tumor will invade important blood vessels during treatment, potentially causing fatal massive hemorrhage; 15. Patients with abnormal coagulation function and a tendency to bleed (must meet the following criteria 14 days before enrollment: INR within the normal range without the use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs; patients are allowed to use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for preventive purposes, provided that the International Normalized Ratio (INR) of prothrombin time is = 200 IU/mL or 1000 copies/mL or >= upper limit of normal), hepatitis C (positive for hepatitis C antibody, and HCV RNA above the detection limit of the analytical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease Control Rate, DCR;Overall Survival, OS;Adverse Event, AE;Duration of response (DoR); | — |
Countries
China
Contacts
Public ContactJingde Chen
Shanghai East Hospital
Outcome results
None listed