OncoMatch/Clinical Trials/NCT06643793
Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC
Is NCT06643793 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Irinotecan liposome (ll) + 5-FU/LV + bevacizumab for colorectal neoplasms malignant.
Treatment: Irinotecan liposome (ll) + 5-FU/LV + bevacizumab — To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: MSH2 deficient mismatch repair
Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry
Excluded: MSH6 deficient mismatch repair
Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry
Excluded: MLH1 deficient mismatch repair
Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry
Excluded: PMS2 deficient mismatch repair
Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry
Excluded: MSH2 microsatellite instability-high
microsatellite high instability (MSI-H) status confirmed by second-generation sequencing (NGS) polymerase chain reaction (PCR) methods
Excluded: MSH6 microsatellite instability-high
microsatellite high instability (MSI-H) status confirmed by second-generation sequencing (NGS) polymerase chain reaction (PCR) methods
Excluded: MLH1 microsatellite instability-high
microsatellite high instability (MSI-H) status confirmed by second-generation sequencing (NGS) polymerase chain reaction (PCR) methods
Excluded: PMS2 microsatellite instability-high
microsatellite high instability (MSI-H) status confirmed by second-generation sequencing (NGS) polymerase chain reaction (PCR) methods
Excluded: BRAF V600E
BRAF V600E mutation
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: oxaliplatin-based therapy — first- or second-line
Prior first- or second-line oxaliplatin-based therapy with treatment failure or intolerance
Cannot have received: irinotecan-based chemotherapy (irinotecan, irinotecan liposome)
Previous treatment with irinotecan/irinotecan liposome-based chemotherapy
Lab requirements
Blood counts
WBC ≥ 3.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L; Hb ≥ 90 g/L
Kidney function
serum creatinine ≤ 1.5x ULN or endogenous creatinine clearance ≥ 60 mL/min
Liver function
ALT/AST ≤ 2.5x ULN (≤ 5x ULN with liver metastasis); total bilirubin ≤ 1.5x ULN; serum albumin ≥ 30 g/L
Cardiac function
normal 12-lead ECG or abnormal without clinical significance; QTcF < 450 ms (men), < 470 ms (women); LVEF ≥ 50%
No major organ dysfunction...see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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