XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer

NCT03511183 | Unknown Phase 2

• 1 other identifier: 2018-51-IIT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. It has been shown that the alternate use of the two drug combinations is reasonable in clinical. This application can not only further improve the curative effect but also significantly reduce the side effects. So the investigators are going to carry out a prospective phase II clinical study. The control group change to second-line treatment after progression of first-line drugs. The experimental group use the first line and the second line,alternately, for every two cycles. The combination of bevacizumab is a first line development, and the second line can still be used . Objective to compare the clinical value of XELOX + bevacizumab and XELIRI + bevacizumab alternation regimen in the first-line treatment of advanced colorectal cancer.

Conditions

Colorectal Neoplasms; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Adverse events will be evaluated according to NCI CTCAE 4.0

  22 months

• Time to failure of strategy（TFS）

  Time from the beginning of the treatment until appear the following events, including death and implementation.the progress of disease,

  22 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  22 months

• Disease control rate(DCR)

  22 months

• Overall Survival (OS)

  22 months

• Time to failure of strategy（TFS）

  22 months

Study Arms (2)

alternative regiment

EXPERIMENTAL

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.

Drug: XELIRI + bevacizumab; Drug: XELOX + bevacizumab

classical regiment

PLACEBO COMPARATOR

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.

Drug: XELIRI + bevacizumab; Drug: XELOX + bevacizumab

Interventions

XELIRI + bevacizumab DRUG

Irinotecan，200mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle

alternative regiment; classical regiment

XELOX + bevacizumab DRUG

Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle

alternative regiment; classical regiment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
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• 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.

You may not qualify if:

• 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.
• Pregnant or lactating women;

Sponsors & Collaborators

• Harbin Medical University: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Fudan University: collaborator
• Sun Yat-sen University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Shengjing Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• Jinzhou Medical University: collaborator

Study Sites (1)

Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; XELOX

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yu Han, doctor

CONTACT

+86-451-86298303; hanyuemail@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 27, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

CN (1)