Actively Recruiting
Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy 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
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer, and this study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line treatment of patients with advanced colorectal cancer.
CONDITIONS
Official 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 18-75 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 by imaging according to RECIST 1.1, not previously treated locally by radiotherapy unless progression is confirmed.
- Adequate vital organ function as specified, including blood counts, liver and kidney function, and coagulation parameters.
- Female subjects of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment and use effective contraception during the trial and for 3 months after.
- Male subjects with partners of childbearing potential must use effective contraception during the trial and for 3 months after.
You will not qualify if you...
- Received local radiotherapy within 4 weeks prior to first dose and not recovered from related adverse events, except palliative radiotherapy to peripheral sites if recovered.
- Active central nervous system metastases or carcinomatous meningitis; stable brain metastases allowed if no steroids used for 28 days.
- Major surgery, open biopsy, or severe trauma within 28 days before treatment.
- History of hypersensitivity to fluorouracil or irinotecan.
- Uncontrolled hypertension (systolic 2140 mmHg or diastolic 290 mmHg).
- Uncontrolled cardiovascular symptoms or diseases including certain heart failure, unstable angina, recent myocardial infarction, or poorly controlled arrhythmias.
- Significant bleeding symptoms or bleeding tendencies within 3 months prior.
- Arterial or venous thrombotic events within 6 months prior, excluding superficial venous thrombosis.
- Another progressing malignancy requiring aggressive treatment, except specific skin or cervical cancers.
- Pregnant or breastfeeding women.
- Other serious illnesses, abnormal lab values, or social factors that could affect safety or trial participation as judged by the investigator.
AI-Screening
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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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