Actively Recruiting
A Multinational, Randomized, Phase III Study of FOLFIRI With/Without Bevacizumab Versus Irinotecan With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2026-06-05
280
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of FOLFIRI chemotherapy with or without Bevacizumab compared to Irinotecan (CPT-11) with or without Bevacizumab as a second-line treatment for patients with metastatic colorectal cancer. This Phase III study aims to determine whether overall survival with FOLFIRI is not worse than with Irinotecan. Key goals include assessing progression-free survival, overall survival, time to treatment failure, response rates, disease control, and safety. The study involves two experimental treatment groups. One group receives Bevacizumab intravenously on day 1 of a two-week cycle, combined with CPT-11, l-LV (or dl-LV), and 5-FU given as both a bolus and continuous infusion over 46 hours. The other group receives Bevacizumab with CPT-11 only, also on day 1 of a two-week cycle. These infusions are repeated every two weeks during the treatment period. Participants will undergo regular monitoring including assessments of tumor progression and response at scheduled intervals, laboratory tests to check organ function, and recording of any adverse events up to 24 weeks. The primary outcome, progression-free survival, is tracked until 1.5 years after the last patient is enrolled. Secondary outcomes such as overall survival and time to treatment failure are also measured during this period. This study requires informed consent and includes safety follow-up to ensure participant well-being throughout the trial.
CONDITIONS
Brief Title
A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically-confirmed inoperable colorectal adenocarcinoma excluding appendix and anal canal cancers
- Age 18 years or older at the time of informed consent
- ECOG performance status of 0 to 2
- Written informed consent obtained before study screening
- Life expectancy of at least 90 days
- Withdrawal from first-line chemotherapy due to toxicity or disease progression, or relapse within 180 days after adjuvant chemotherapy
- Adequate organ function based on specified blood counts and liver and kidney tests within 14 days before enrollment
You will not qualify if you...
- History of other malignancy with disease-free interval less than 5 years (except certain treated skin and cervical cancers)
- Presence of massive pleural effusion or ascites needing intervention
- Radiological evidence of brain tumor or brain metastases
- Active infection including hepatitis
- Gastrointestinal bleeding or obstruction, symptomatic heart disease, interstitial pneumonia, uncontrolled diabetes or diarrhea
- Recent myocardial infarction or serious hypersensitivity to study drugs
- Previous treatment with irinotecan hydrochloride
- Current treatment with atazanavir sulfate
- Recent treatment with tegafur, gimeracil, and oteracil potassium
- Pregnancy or lactation, or unwillingness to use contraception
- Continuous systemic steroid treatment
- Psychiatric disability affecting compliance
- Unsuitability for participation per investigator decision
- Recent gastrointestinal perforation or pulmonary hemorrhage
- Recent major surgery
- Unhealed wounds, ulcers, or fractures
- Recent thromboembolism or cerebrovascular disease
- Anticoagulation therapy exceeding 325 mg/day aspirin
- Bleeding disorders or coagulation abnormalities
- Uncontrolled hypertension
- Significant proteinuria on urine test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1.5 years or until disease progression or discontinuation
Participants receive chemotherapy with either FOLFIRI with or without Bevacizumab, or Irinotecan with or without Bevacizumab, administered in 2-week cycles.
Bi-weekly visits corresponding to each 2-week treatment cycle
Duration - Up to 1.5 years after last patient enrollment
Participants are monitored for progression-free survival, overall survival, and safety outcomes after treatment ends.
Periodic visits for assessments up to 1.5 years after treatment ends
Trial Site Locations
Total: 1 location
1
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
R
Ruihua Xu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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