Actively Recruiting
New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer
Led by The First Hospital of Jilin University · Updated on 2026-04-30
30
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed colorectal adenocarcinoma
- Unresectable MSS-type metastatic colorectal cancer that failed or is intolerant to first-line oxaliplatin plus fluoropyrimidine with or without targeted therapy
- Disease progression during or within 3 months after first-line treatment, or progression within 6 months after adjuvant oxaliplatin-based therapy
- At least one measurable tumor lesion by RECIST 1.1
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function within 14 days before enrollment, including specified blood counts, coagulation, kidney, liver, and heart function
- Voluntary written informed consent and ability to comply with study procedures
- Women of childbearing potential must have a negative pregnancy test within 3 days before first study dose
- Men and women with reproductive potential must use effective contraception from screening until 120 days after last study drug or 180 days after last chemotherapy, whichever is later
You will not qualify if you...
- Prior treatment with topoisomerase-I inhibitors or similar drugs in first-line therapy
- Known allergy or hypersensitivity to any study drug or ingredients
- Pregnant or breastfeeding women
- Unresolved toxicities from prior treatments above CTCAE Grade 1 (except alopecia or low-risk toxicities)
- Any cancer therapy within 4 weeks before first study dose or recent major surgery not fully healed
- Severe psychiatric or psychological disorders affecting compliance
- Significant cardiovascular disease including recent severe heart events or abnormal ECG QTc intervals
- Active infections or unexplained fever above 38.5°C at screening or dosing day
- Serious infections requiring hospitalization within 4 weeks
- Active lung inflammation or need for systemic antibiotics (prophylactic antibiotics allowed)
- Known HIV infection, active hepatitis B or C unless controlled
- History or current leptomeningeal or active brain metastases unless stable and treated
- Other severe uncontrolled diseases such as frequent seizures or liver failure
- Other cancers within 5 years except treated skin basal-cell carcinoma or cervical carcinoma in situ
- Participation in another clinical trial within 4 weeks or less than 5 half-lives of previous investigational drug
- Any condition that may interfere with consent, participation, or result interpretation as judged by investigator
- Investigator deems patient unsuitable for enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
C
Chang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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