OncoMatch/Clinical Trials/NCT06341296
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
Is NCT06341296 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Irinotecan Liposome and 5-FU for metastatic colorectal cancer.
Treatment: Irinotecan Liposome · 5-FU · LV · Bevacizumab — To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: KRAS mutation
RAS/BRAF v600e mutant or right half colon cancer is known.
Allowed: NRAS mutation
RAS/BRAF v600e mutant or right half colon cancer is known.
Allowed: BRAF V600E
RAS/BRAF v600e mutant or right half colon cancer is known.
Allowed: MLH1 proficient mismatch repair
pMMR/MSS is known.
Allowed: MSH2 proficient mismatch repair
pMMR/MSS is known.
Allowed: MSH6 proficient mismatch repair
pMMR/MSS is known.
Allowed: PMS2 proficient mismatch repair
pMMR/MSS is known.
Disease stage
Required: Stage IV
Metastatic disease required
The unresectable stage of metastatic disease has not received any systemic antitumor therapy. The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: irinotecan (irinotecan, irinotecan liposomes)
Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
Cannot have received: VEGF inhibitor (bevacizumab)
Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
Lab requirements
Blood counts
Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10^9/L, and no bleeding tendency
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min (Cockroft-Gault)
Liver function
AST, ALT and alkaline phosphatase (ALP) ≤2.5× ULN, and ≤5×ULN when liver metastases occurred; total bilirubin ≤ ULN
Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10^9/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40 ml/min (calculated according to Cockroft-Gault)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06341296 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy 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 85 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