- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511183
XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
A Randomized, Open, Controlled, Multicenter,Phase II Clinical Trial of XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yu Han, doctor
- Phone Number: +86-451-86298303
- Email: hanyuemail@163.com
Study Locations
-
-
Heilongjiang
-
Harbin, Heilongjiang, China
- Recruiting
- Harbin Medical University
-
Contact:
- Yu Han, doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed as colorectal adenocarcinoma by histopathology and/or cytology.
- Patients could not receive surgical resection.
- Never received chemotherapy or radiotherapy.
- According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
- Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score
The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).
- Hemoglobin(HB)≥90g/L;
- Absolute neutrophil count (ANC) ≥1.5×10^9/L;
- Blood platelet (PLT)≥80×10^9/L; (2) Biochemical examination should comply with the following criteria:
- Bilirubin(BIL) <1.5 times of the upper limit of normal value (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5*ULN (liver metastasis ALT and AST<5*ULN).
- Serum Cr≤1*ULN, creatinine clearance rate≥50ml/min (Cockcroft-Gault formula)
- The expected survival time more than 3 months;
- The physicians plan to use XELOX + bevacizumab chemotherapy or XELIRI+bevacizumab chemotherapy.
- Patients voluntarily joined the study and signed informed consent form (ICF).
- Child bearing age women must undergo a negative pregnancy test (serum or urine) within 7 days ,and voluntarily adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug; As for men, it is necessary to receive surgical sterilization, or agree to adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug.
Exclusion Criteria:
There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
- Acute coronary artery syndrome
- Acute heart failure (grade III or IV of NYHA classification)
Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation).
(2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months. (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
- There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
- ECOG score≥2
- Abnormal coagulation function (INR>1.5*ULN, Activated partial thromboplastin time(APTT)>1.5*ULN), with bleeding tendency.
- There is any history of allergy or hypersensitivity in this research's drug or adjuvant.
- HIV infection and/or active hepatitis B virus infection.
- Any condition that may damage the safety of patients or the integrity of research data, including serious medical risk factors, physical condition and laboratory abnormality.
- The high risk population carrying UGT1A1*28 (7/7) *6 (A/A) genotype or simultaneous carrying of the UGT1A1*28 (6/7) *6 (A/G) genotype (the heterozygous genotype) suggests the exclusion of the Irinotecan
- Pregnant or lactating women;
- Other conditions which the doctor think not suitable for inclusion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: alternative regiment
The first stage:XELOX + bevacizumab chemotherapy and XELIRI + bevacizumab chemotherapy (alternation of every two cycles) until one of the schemes appears imaging progress or intolerance.And then enter the second stage. The second stage: continue to apply another plan until there is progress or intolerance. |
Irinotecan,200mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg
,d1; every 21 days as a cycle
Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg
,d1; every 21 days as a cycle
|
Placebo Comparator: classical regiment
Use the XELOX + bevacizumab chemotherapy until appears imaging progress or intolerance.And then change to the XELIRI + bevacizumab chemotherapy until there is progress or intolerance.
|
Irinotecan,200mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg
,d1; every 21 days as a cycle
Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg
,d1; every 21 days as a cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 22 months
|
Adverse events will be evaluated according to NCI CTCAE 4.0
|
22 months
|
Time to failure of strategy(TFS)
Time Frame: 22 months
|
Time from the beginning of the treatment until appear the following events, including death and implementation.the
progress of disease,
|
22 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 22 months
|
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
|
22 months
|
Disease control rate(DCR)
Time Frame: 22 months
|
The rate of cases of remission and stable disease accounts for the total evaluable cases after treatment
|
22 months
|
Overall Survival (OS)
Time Frame: 22 months
|
Overall survival time after the beginning of the treatment
|
22 months
|
Time to failure of strategy(TFS)
Time Frame: 22 months
|
Time from the second beginning of the treatment until appear the following events, including death and implementation.the
progress of disease,
|
22 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- 2018-51-IIT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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