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This is a single-arm, open-label clinical trial designed to evaluate the efficacy and safety of irinotecan liposome (II), 5-FU/LV in combination with bevacizumab for the treatment of advanced colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Bevacizumab: 5 mg/kg, intravenous infusion, Day 1; Irinotecan liposome (II): 60 mg/m² (based on free base), intravenous infusion for at least 90 minutes, Day 1 ; 5-FU: 400 mg/m², intravenous bolus injection, Day 1; followed by 1200 mg/(m²·day) × 2 days of continuous intravenous infusion (total dose 2400 mg/m², infused over 46-48 hours); LV: 400 mg/m², intravenous infusion over 2 hours, Day 1; Q2w, continued until an event meeting the treatment discontinuation criteria occurs or the subject withdraws from the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab,Irinotecan liposome (II),5-FU/LV | Drug | Bevacizumab: 5 mg/kg, intravenous infusion, Day 1; Irinotecan liposome (II): 60 mg/m² (based on free base), intravenous infusion for at least 90 minutes, Day 1; 5-FU: 400 mg/m², intravenous bolus injection, Day 1; followed by 1200 mg/(m²·day) × 2 days of continuous intravenous infusion (total dose 2400 mg/m², infused over 46-48 hours); LV: 400 mg/m², intravenous infusion over 2 hours, Day 1; Q2w, continued until an event meeting the treatment discontinuation criteria occurs or the subject withdraws from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety:The incidence of adverse events | Proportion of patients experiencing ≥3 grade adverse events (AE) (%);Proportion of patients experiencing AE leading to drug discontinuation (%);Proportion of patients experiencing diarrhea (all grades) (%);Proportion of patients experiencing neutropenia (all grades) (%) | start of treatment until 3-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | start of treatment until 1-year follow-up | |
| Disease control rate(DCR) | start of treatment until 1-year follow-up | |
| Progression-free survival(PFS) |
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Inclusion Criteria:
(1) Complete blood count (no blood transfusion or use of leukocyte or platelet-enhancing agents within 14 days prior to screening): hemoglobin > 90 g/L; neutrophil count > 1.5 × 10⁹/L; platelet count > 100 × 10⁹/L;(2) Biochemical tests: total bilirubin ≤ 1.5×ULN (upper limit of normal); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2×ULN; if liver metastasis is present, ALT and AST ≤ 5×ULN; endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.
7. Any damage caused by other treatments has recovered; 8. The subject voluntarily participates in this study, has signed an informed consent form, has good compliance, and cooperates with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjun Cai, PhD | Contact | +8613901815189 | caisanjuncsj@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University, Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| start of treatment until 2-year follow-up |
| Overall survival (OS) | start of treatment until 3-year follow-up |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C584112 | irinotecan sucrosofate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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