OncoMatch/Clinical Trials/NCT06643793
Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC
Is NCT06643793 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06643793 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior irinotecan-based chemotherapy disqualifies patients from enrollment.
Are patients with MSH2 alterations eligible?
No. MSH2 deficient mismatch repair is an exclusion criterion.
Are patients with MSH6 alterations eligible?
No. MSH6 deficient mismatch repair is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages