Actively Recruiting
Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.
Led by Chinese PLA General Hospital · Updated on 2025-07-01
30
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.
CONDITIONS
Official Title
Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients agree and have signed an informed consent form and can comply with study procedures
- Age 18 years or older, any gender
- Pathologically confirmed advanced colorectal cancer
- Received at least second-line systemic antitumor therapy including irinotecan regimen
- At least one measurable lesion by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival of 3 months or more
- Normal major organ function with specified laboratory values
- Use of medically approved contraception during study and for 6 months after
- Negative serum HCG test within 7 days before enrollment for those with potential fertility
- Non-lactating
You will not qualify if you...
- Other active malignant tumors except cured skin basal cell carcinoma and cervical carcinoma in situ
- Participation in other drug trials within 4 weeks prior to enrollment
- Severe gastrointestinal dysfunction or recent serious gastrointestinal conditions
- Clinical symptoms of ascites needing drainage
- Unstable third fluid accumulations such as large pleural effusions
- Active gastrointestinal bleeding or recent history of black stool or vomiting blood
- Known interstitial lung disease except minor imaging changes
- Known or suspected central nervous system metastases
- Use of strong CYP3A4, CYP2C8, or UGT1A1 inhibitors/inducers within 2 weeks
- Poorly controlled hypertension or recent serious cardiac conditions
- Allergies to study drugs or related products
- Abnormal coagulation or bleeding tendencies outside allowed limits
- Refusal or inability to use contraception as required
- Active hepatitis B or C infection, HIV, or active syphilis
- Active infection or recent high fever or antibiotic treatment
- History of neurological or mental disorders including epilepsy or dementia
- Serious diseases affecting safety or study completion as assessed by investigator
- Other conditions affecting study progress or results as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital, Beijing,
Beijing, China
Actively Recruiting
Research Team
G
Guanghai Dai, Doctor
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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