Status:
UNKNOWN
A Phase I/II Study of XELOXIRI and Bevacizumab as First-line Treatment in Metastatic Colorectal Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Metastatic Cancer
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The phase I/II study was designed to evaluate if the regimen of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab is a superior first-line option for patients with metastatic colorectal...
Detailed Description
Recent studies have shown that the triplet-drug regimen FOLFOXIRI (irinotecan/oxaliplatin/fluorouracil) can further improves survival benefit for patients with metastatic colorectal cancer(mCRC) compa...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed metastatic colorectal adenocarcinoma;
- Age 18-80 years old;
- Eastern Cooperation Oncology Group (ECOG) performance score(\<2);
- At least one measurable lesion for disease assessment according to RECIST version 1.1;
- Able to take oral medications;
- Previous fluoropyrimidine-based adjuvant or neoadjuvant chemotherapy was allowed only when it ended ≥ 6 months before study enrollment;
- No previous therapy for mCRC;
- Adequate organ functions as assessed by the following laboratory requirements: Leukocytes≥3.0x109/L, absolute neutrophil count≥1.5x109/L, platelet count≥100x109/L, hemoglobin≥9g/dL; serum bilirubin≤1.5x the upper limit of normal(ULN);Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤3x ULN; serum creatinine≤1.5x ULN; calculated creatinine clearance or 24 hour creatinine clearance ≥60ml/min.
- An expected survival of at least 3 months;
- Willingly provide written informed consent to study procedures.
Exclusion
- Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
- With a history of extensive enterotomy or pelvic radiation therapy; Suffering from grade 2 or higher symptomatic peripheral neuropathy according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
- Uncontrolled central nervous system metastasis, disseminated intravascular coagulation or active infection;
- With concurrent cancer distinct from colorectal adenocarcinoma except cured skin basal cell carcinoma and cervical carcinoma in situ;
- Undergone a major operation, open biopsy or major traumatic injury within 28 days before study enrollment or have potential to receive major operation during the trial;
- Received central venous access device within 2 days before study enrollment;
- Any kind of concurrent cardiac disease with clinical meanings, such as cardiovascular accident, myocardial infarction, thromboembolism or hemorrhage within 6 months before enrollment, congestive heart failure ≤New York Heart Association (NYHA) class 2 or uncontrolled hypertension.
- With positive urine protein and 24-hour urinary protein content\>1g;
- Have a tendency of bleeding or clotting;
- With nasty open wounds, ulcers or fractures;
- Current or recent treatment of anticoagulants, antiplatelet agent or nonsteroidal anti-inflammatory drugs, while aspirin of daily dose less than 325mg is allowed.
- With any illness or medical conditions that may jeopardize the patient's compliance or interfere the analyses or judgements of study results;
- Pregnancy or lactation at the time of study entry;
- With fertility but refuse to contraception.
Key Trial Info
Start Date :
April 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04380103
Start Date
April 26 2020
End Date
September 1 2022
Last Update
May 8 2020
Active Locations (2)
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1
National Center/Cancer Hospital, China Academy of Medical Science and Peking Union Medical College
Beijing, China
2
National Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China