Colorectal cancer
Conditions
Interventions
liposomal irinotecan+5-FU/LV+ bevacizumab group:liposomal irinotecan 70 mg/m^2
LV 400 mg/m^2
5-FU 2400 mg/m^2
bevacizumab 5 mg/kg
d1, Q2W
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age:18-75 years old. 2. Histologically or cytologically proven colon or rectum adenocarcinoma. 3. Confirmed as unresectable metastatic disease through radiological examination. 4. At least one measurable lesion (according to RECIST v1.1). 5. First-line treatment with oxaliplatin-based therapy (Adjuvant treatment with recurrence = 6 months after the last medication is considered first-line treatment). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 2. 7. The expected survival time =3 months. 8. Subject has adequate biological parameters as demonstrated by the following: Absolute neutrophil count (ANC) =1.5×10^9/L Platelet count =100×10^9/L Hemoglobin (Hgb) =90 g/L White blood cell(WBC)=3.0×10^9/L 9. Adequate hepatic function as evidenced by: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) = 2.5 × ULN (upper limit of normal value), = 5× ULN in case of liver metastasis ; Total bilirubin = 1.5 × ULN; 10. Adequate renal function as evidenced by serum creatinine (Cr)=1.5 × ULN or creatinine clearance =60 mL/min, proteinuria <2+. 11. Normal coagulation function (INR=1.5). 12. Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Exclusion criteria
Exclusion criteria: 1. Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma. 2. Previous treatment with irinotecan/liposomal irinotecan. 3. Known as microsatellite height instability (MSI-H) or mismatch repair defect (dMMR). 4. A large amount of pleural effusion or ascites requires drug intervention treatment; 5. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment. 6. Known active HIV infection; Untreated active HBV and HCV infections;. 7. Combined with uncontrollable systemic diseases, such as New York Heart Association (NYHA) grade II or higher heart disease; uncontrolled hypertension(Defined as systolic blood pressure=140 mmHg and/or diastolic blood pressure=90 mmHg after treatment with standardized antihypertensive drugs), or history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes, etc. 8. Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction , > grade 1 diarrhea or gastrointestinal perforation) 9. History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrolment. 10. Presence of interstitial pneumonia or pulmonary fibrosis. 11.Allergy to or intolerance to therapeutic drugs or their excipients;. 12. History of pulmonary hemorrhage/hemoptysis = Grade 2 (defined as bright red blood of at least 2.5mL) within one month prior to enrollment. 13. Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before enrollment. 14. Symptomatic central nervous system metastases. 15. Documented serum albumin =3 g/dL 16. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. 17. Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception. 18. Those who have received any intravenous anti-tumor therapy within 28 days prior to the first dose of the study drug, or those who have used oral anti-tumor drugs within 14 days; 19. Participated in other trial within 30 days prior to the first dose of study treatment. 20. Patients who are not suitable to participate in this trial for any reason judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;Duration of Response;Progress-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactGuiying Wang
The Fourth Hospital of Hebei Medical University
Outcome results
None listed