BridgeMD
New treatment option for Colorectal Neoplasms
Official title A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC
ClinicalTrials.gov ID: NCT03303495
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal neoplasms.
Also referred to as Avastin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
- Age ≥18 years at the time of informed consent
- ECOG performance status (PS) of 0-2
- Written informed consent prior to study-specific screening procedures
- Life expectancy of at least 90 days
You likely can't join if
- History of other malignancy with a disease-free interval \<5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated...
- With massive pleural effusion or ascites requiring intervention
- Radiological evidence of brain tumor or brain metastases
- Active infection including hepatitis
- Any of the following complication: i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart...
- Any of the following medical history: Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime...
See the full eligibility criteria
- Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
- Age ≥18 years at the time of informed consent
- ECOG performance status (PS) of 0-2
- Written informed consent prior to study-specific screening procedures
- Life expectancy of at least 90 days
- Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last...
- Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the...
- History of other malignancy with a disease-free interval \<5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer...
- With massive pleural effusion or ascites requiring intervention
- Radiological evidence of brain tumor or brain metastases
- Active infection including hepatitis
- Any of the following complication: i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart...
- Any of the following medical history: Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes i) Serious hypersensitivity to any of the study drugs ii) History of...
- Previous treatment with irinotecan hydrochloride
- Current treatment with atazanavir sulfate
- Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment
- Pregnant or lactating females, and males and females unwilling to use contraception
- Requires continuous treatment with systemic steroids
- Psychiatric disability that would preclude study compliance
- Otherwise determined by the investigator to be unsuitable for participation in the study
- Concurrent gastrointestinal perforation or history of gastrointestinal perforation with 1 year before enrollment
- History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within 1 month prior to enrollment.
- History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrollment
- Unhealed wound (except suture wounds from implantation of a central venous port), gastrointestinal ulcer, or traumatic fracture
- Current or recent (within 1 year) thromboembolism or cerebrovascular disease
- Currently receiving or requires anticoagulation therapy (\> 325 mg/day of aspirin)
- Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)
- Uncontrolled hypertension
- Urine dipstick for proteinuria \>+2
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.