A Phase I/II Study of XELOXIRI and Bevacizumab as First-line Treatment in Metastatic Colorectal Cancer

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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 cancer(mCRC) in terms of safety and efficacy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Bevacizumab; Capecitabine; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.