Actively Recruiting
A Single-center Phase II Clinical Study of Irinotecan Liposome (II)-Based Combination Regimen as a Treatment for Irinotecan-Resistant Colorectal Cancer.
Led by Chinese PLA General Hospital · Updated on 2025-07-01
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment using irinotecan liposome (II) for patients with colorectal cancer that is resistant to irinotecan. This phase II clinical study aims to observe and assess both the safety and effectiveness of this treatment approach in patients whose cancer has advanced despite previous therapies. The trial is conducted by the Chinese PLA General Hospital and focuses on patients with advanced colorectal cancer who have measurable tumors and have undergone at least second-line systemic cancer treatment. The study treatment combines irinotecan liposome (II), cetuximab, and bevacizumab, all given by intravenous infusion every two weeks starting on Day 1 of each cycle. Dosages are adjusted for certain genetic mutations. Treatment continues in 2-week cycles until cancer progression, unacceptable side effects, initiation of new anti-cancer therapy, patient withdrawal, or investigator decision. If disease progresses as defined by RECIST criteria, treatment may continue if the patient is still benefiting and tolerating it well. Participants will have regular safety visits before each treatment cycle to monitor adverse events. Researchers will measure progression-free survival up to three years as the primary outcome. Secondary outcomes include overall response rate, disease control rate, overall survival, duration of response, and safety measures. Laboratory tests and assessments of organ function will be conducted throughout. The study started in September 2024 and will follow patients until July 2027.
CONDITIONS
Brief 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 are willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other trial procedures
- Age 18 years or older, male or female
- Pathologically confirmed advanced colorectal cancer (excluding other histological types)
- Have received at least second-line systemic antitumor therapy including irinotecan regimen or targeted therapy
- At least one measurable lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Expected survival of 3 months or more
- Normal major organ function with laboratory values within specified ranges including hemoglobin, neutrophils, white blood cells, platelets, liver enzymes, creatinine, and coagulation parameters
- Use of medically recognized contraceptive methods during treatment and for 6 months after, with a negative pregnancy test within 7 days before enrollment and non-lactating status
- Male participants agree to use contraceptive measures during the study and 6 months after
You will not qualify if you...
- Presence or history of other malignant tumors except cured skin basal cell carcinoma or cervical carcinoma in situ
- Participation in other drug clinical trials within 4 weeks prior to enrollment
- Severe gastrointestinal dysfunction such as bleeding, obstruction, or inflammation above grade 2
- Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to enrollment
- Ascites requiring drainage or unstable large fluid accumulations
- Tendency toward gastrointestinal bleeding or recent history of bleeding events
- Known interstitial lung disease or central nervous system metastases
- Use of strong CYP3A4, CYP2C8, or UGT1A1 inhibitors or inducers within 2 weeks prior to enrollment
- Uncontrolled hypertension, unstable angina, recent myocardial infarction, significant cardiac arrhythmias, or heart failure of NYHA class II or higher
- Allergy to any study drug components including irinotecan liposomes, bevacizumab or cetuximab
- Abnormal coagulation or bleeding disorders, or recent use of anticoagulants outside permitted low-dose medications
- Pregnancy, breastfeeding, refusal to use contraception during and after the study period
- Active hepatitis B or C infection, HIV or active syphilis infection
- Active infection or fever above 38.5°C within 1 week prior to enrollment
- History of neurological or mental disorders such as epilepsy or dementia
- Other serious diseases or conditions judged by the investigator to affect patient safety or study completion
- Other conditions that may affect the progress or results of the clinical research as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 2-week cycles until disease progression or discontinuation
Participants receive a combination of irinotecan liposomes, cetuximab, and bevacizumab through intravenous infusions every two weeks to treat irinotecan-resistant colorectal cancer. Treatment continues based on efficacy and tolerance until disease progression, unacceptable toxicity, or withdrawal.
Visits on Day 1 of each treatment cycle for medication and safety assessments
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital, Beijing,
Beijing, China
Actively Recruiting
Research Team
G
Guanghai Dai, Doctor
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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