New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer
This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continu
| Condition(s) | Metastatic Colorectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled. |
| Who can participate | Inclusion Criteria: 1. Male or female, aged 18-75 years. 2. Histologically or cytologically confirmed colorectal adenocarcinoma. 3. Unresectable, MSS-type metastatic colorectal cancer that has failed or is intolerant to first-line standard oxaliplatin plus fluoropyrimidine ± targeted therapy. * Failure definition: progression during or within 3 months after completing first-line oxaliplatin/fluoropyrimidine ± targeted therapy. * Adjuvant setting: progression/recurrence during or within 6 months of completing adjuvant oxaliplatin-based chemotherapy/chemoradiation counts as first-line failure. 4. At least one measurable lesion by RECIST 1.1. 5. ECOG performance status 0-1. 6. Expected survival ≥ 3 months. 7. Adequate organ function within 14 days before enrollment (no transfusion or growth-f |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | The First Hospital of Jilin University |
| Locations | Changchun, Jilin, China |
| Start date | 2025-11-01 |
| NCT ID | NCT07559760 |
| Official listing | https://clinicaltrials.gov/study/NCT07559760 |