New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer (NCT07559760) | Clinical Trial Compass
RecruitingPhase 2
New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer
China30 participantsStarted 2025-11-01
Plain-language 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
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 18-75 years.
✓. Histologically or cytologically confirmed colorectal adenocarcinoma.
✓. Unresectable, MSS-type metastatic colorectal cancer that has failed or is intolerant to first-line standard oxaliplatin plus fluoropyrimidine ± targeted therapy.
✓. At least one measurable lesion by RECIST 1.1.
✓. ECOG performance status 0-1.
✓. Expected survival ≥ 3 months.
✓. Adequate organ function within 14 days before enrollment (no transfusion or growth-factor support):
✓. Voluntary written informed consent; willing and able to comply with study procedures and follow-up.
Exclusion criteria
✕. Prior exposure to topoisomerase-I inhibitors or their analogues in first-line therapy.
✕. Documented hypersensitivity to any study drug or its excipients.
✕. Pregnant or breast-feeding women.
✕. Toxicities from prior therapy not resolved to CTCAE v5.0 Grade ≤ 1 (except alopecia or other toxicities deemed by the investigator to pose no safety risk).
✕. Any anti-cancer therapy (chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, etc.) within 4 weeks before first study-dose; major surgery (excluding biopsy) within 4 weeks that has not fully healed.