OncoMatch/Clinical Trials/NCT07047560
Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study
Is NCT07047560 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) for colorectal cancer (crc).
Treatment: fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) — This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR). Eligible subjects will receive second-line treatment with the FOLFIRInali-3 （Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV） plus bevacizumab (Bev) 。Treatment will be discontinued upon occurrence of any of the following: Disease progression (radiologically confirmed)，intolerable toxicity (unmanageable after dose modification)， initiation of new antitumor therapy, withdrawal of informed consent or investigator's discretion (based on clinical judgment). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (oxaliplatin) — first-line or adjuvant
Patients who experienced disease progression under either of the following circumstances: During or within 6 months after first-line oxaliplatin-containing chemotherapy, or within 1 year after completing oxaliplatin-based adjuvant chemotherapy post-resection
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1500/mm3); Platelet count ≥ 100 × 10^9/L (100000/mm3); Hemoglobin ≥ 90g/L
Kidney function
Creatinine clearance rate (CrCl) ≥ 50 mL/min; Normal urine routine, urine protein <2+ or 24-hour urine protein quantification <1.0 g
Liver function
Total serum bilirubin (TBiL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT can be ≤ 5 × ULN; Serum albumin (ALB) ≥ 30g/L
Normal organ function: Hematology: ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 90g/L; Kidney: CrCl ≥ 50 mL/min; Normal urine routine, urine protein <2+ or 24-hour urine protein quantification <1.0 g; Liver: TBiL ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT can be ≤ 5 × ULN; Serum albumin (ALB) ≥ 30g/L; Normal coagulation function, INR ≤ 1.5 x ULN, PT and APTT ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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