Actively Recruiting
Clinical Study of Second-line Treatment of Patients With Advanced Colorectal Cancer Using Irinotecan Liposome (II), Fluorouracil Combined With Bevacizumab or Cetuximab
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-22
100
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of liposomal irinotecan (II) combined with fluorouracil and either bevacizumab or cetuximab for the second-line treatment of patients with advanced metastatic colorectal cancer. This phase 2 study focuses on comparing the efficacy and safety of these combinations, as guidelines recommend FOLFIRI with bevacizumab or cetuximab for this condition. Liposomal irinotecan may offer improved treatment results compared to ordinary irinotecan. Participants receive either irinotecan liposome (II) and fluorouracil with bevacizumab or irinotecan liposome (II) and fluorouracil with cetuximab. The treatment includes an induction phase and a maintenance phase, where bevacizumab or cetuximab is combined with irinotecan liposome (II) or Capecitabine. These regimens are studied to monitor their impact on cancer progression and patient safety. During the study, participants undergo regular assessments including imaging scans to measure tumor response, evaluations of progression-free and overall survival, and monitoring for adverse events. Quality of life is also assessed. The study lasts for about one year on average for the primary outcome and up to 50 months for safety and quality of life evaluations. The trial aims to gather detailed information on how patients respond and tolerate these treatments over time.
CONDITIONS
Brief Title
Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent to voluntarily enroll in this study.
- Men or women aged 18 to 75 years.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
- Patients who have failed one prior systemic therapy.
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
- Life expectancy of at least 3 months.
- Measurable lesions at baseline assessed by imaging (RECIST 1.1), not previously treated locally unless progression is confirmed.
- Adequate vital organ function as defined by specific blood counts and biochemical measures.
- Female subjects of childbearing potential must have a negative pregnancy test and use effective contraception during and for 3 months after treatment; males with partners of childbearing potential must also use effective contraception during and for 3 months after treatment.
You will not qualify if you...
- Received local radiotherapy within 4 weeks before first study drug dose without recovery from adverse events.
- Known active central nervous system metastases or carcinomatous meningitis.
- Major surgery, open biopsy, or severe trauma within 28 days prior to first dose.
- History of hypersensitivity to fluorouracil or irinotecan.
- Uncontrolled hypertension (systolic 240 mmHg or diastolic 290 mmHg).
- Uncontrolled cardiovascular conditions including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias.
- Clinically significant bleeding or bleeding tendency within 3 months prior to first dose.
- Arterial or venous thrombotic events within 6 months prior to first dose.
- Other progressing malignancies requiring treatment except certain skin and cervical cancers.
- Pregnant or breastfeeding women.
- Other serious illnesses, abnormal lab values, or social factors that may affect safety or data collection as judged by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive induction therapy with irinotecan liposome (II) and fluorouracil in combination with either bevacizumab or cetuximab, followed by maintenance therapy with bevacizumab or cetuximab combined with irinotecan liposome (II) or Capecitabine.
Visits occur throughout induction and maintenance therapy according to treatment schedule
Duration - Up to 50 months
Participants are monitored for progression-free survival, overall survival, adverse events, and quality of life after completing treatment.
Periodic visits for assessments up to 50 months post-treatment
Trial Site Locations
Total: 1 location
1
The second affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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