Status:
NOT_YET_RECRUITING
Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer
Lead Sponsor:
Harbin Medical University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This multicenter, single-arm trial will explore the efficacy and safety of liposomal irinotecan and capecitabine plus bevacizumab as second-line therapy in metastatic colorectal cancer.
Detailed Description
Colorectal cancer (CRC) has a poor prognosis and poses a serious threat to human health. irinotecan + fluorouracil ± angiogenesis inhibitors are common treatments for advanced CRC. For patients receiv...
Eligibility Criteria
Inclusion
- Age: ≥18 years old.
- Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma, and patients failed or are intolerant to first-line treatment with oxaliplatin ± VEGF/EGFR.
- At least one measurable lesion (according to RECIST v1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
- The expected survival time ≥3 months.
- 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.
- Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, ≤5 × ULN if liver metastases are present. Serum albumin ≥3 g/dL.
- Adequate renal function as evidenced by serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. Proteinuria \< 2+ (those with proteinuria ≥2+ at baseline had to demonstrate ≤1 g protein per 24 hours).
- Coagulation function: International normalised ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Left ventricular ejection fraction (LVEF) ≥50%.
- Subjects agree to use contraception and are not pregnant or breastfeeding women.
- Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Exclusion
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Previous treatment with irinotecan/liposomal irinotecan.
- Patients with the primary lesion located in the left colon and RAS/BRAF wild-type who did not use cetuximab on the first line.
- Known as high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
- Massive pleural effusion or ascites requiring intervention.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV infection.
- Combined with uncontrollable systemic diseases within 6 months before the first administration.
- Presence of severe gastrointestinal disease.
- History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration, or plan to undergo major surgery during the study period.
- Presence of interstitial pneumonia or pulmonary fibrosis.
- History of allergy or hypersensitivity to drug or any of their excipients.
- History of pulmonary hemorrhage/hemoptysis ≥Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration.
- Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before the first administration.
- Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome.
- Use of strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1 within 14 days before the first administration.
- Use other study drug within 1 month before the first administration.
- Patients who are not suitable to participate in this trial for any reason judged by the investigator.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06192680
Start Date
April 1 2024
End Date
September 30 2026
Last Update
January 18 2024
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