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A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer

Primary Purpose

Advanced Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine
Sponsored by
Jiangsu Cancer Institute & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-75 years old;
  2. Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or with metastasis more than 12 months after radical operation, and the metastasis could not be removed;
  3. ECOG score ≤ 2, estimated survival time ≥ 3 months;
  4. Leucocytes ≥ 3.5 × 109 / L, neutrophils ≥ 1.5 × 109 / L, hemoglobin ≥ 100g / L, platelets ≥ 80 × 109 / L, serum liver enzyme in patients without liver metastasis is not higher than 2.5 times of the upper limit of normal value, serum liver enzyme in patients with liver metastasis is not higher than 5 times of the upper limit of normal value, serum bilirubin level is not higher than 1.5 times of the upper limit of normal value, serum creatinine level is not higher than 1.5 times of the upper limit of normal value;
  5. At least one lesion can be measured by CT or MRI;
  6. No other history of malignant tumor;
  7. Those who are fertile but willing to take contraceptive measures;
  8. Sign the written informed consent.

Exclusion Criteria:

  1. Patients with allergic, hypersensitive constitution and autoimmune diseases;
  2. There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatous lymphangitis, diffuse liver invasion and bone metastasis; No measurable or non assessable lesions;
  3. Pregnant or lactated women;
  4. Uncontrolled symptomatic brain metastasis or mental disorder can not correctly describe subjective symptoms;
  5. Major organ failure;
  6. Affecting drug administration, absorption, distribution, metabolism, excretion, etc. the patient has uncontrollable epileptic attack, central nervous system disorder or loss of self-knowledge due to mental disease, physiological or pathological malnutrition, chronic diarrhea, and cachexia;
  7. Patients with complete or incomplete ileus;
  8. Patients with serious heart disease or history, including documented history of congestive heart failure, high-risk uncontrolled heart rate disorder, angina requiring drug treatment, clinically clear history of heart valve disease, serious myocardial infarction and stubborn hypertension;
  9. Severe uncontrollable infection;
  10. Alcohol and /or drug abuse or poor compliance of the investigator's judgment.

Sites / Locations

  • Jiangsu Cancer Institute & HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI

Arm Description

Induction chemotherapy: Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI: Bevacizumab: 5mg/kg, iv, 30min, d1, 2w; Oxaliplatin: 85mg/㎡, iv, 120min, d1, 4w; Irinotecan: 150mg/㎡, iv, 90min, d15, 4w; Capecitabine: 1000mg/㎡, bid, d2-8, 2w. Maintenance chemotherapy: Bevacizumab: 7.5mg/kg, iv, 30min, d1, q3w; Capecitabine: 1000mg/㎡, bid, d2-15, 2w.

Outcomes

Primary Outcome Measures

Progression Free Survival 1 (PFS 1)

Secondary Outcome Measures

Progression Free Survival 2 (PFS 2)
Objective Response Rate (ORR)
Overall Survival (OS)
The occurrence of adverse reactions (AEs)

Full Information

First Posted
March 25, 2020
Last Updated
August 27, 2021
Sponsor
Jiangsu Cancer Institute & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04324476
Brief Title
A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer
Official Title
A Multicenter Phase II Clinical Study of Bevacizumab Combined With Biweekly XELOX/XELIRI Alternative First-line Treatment for Unresectable Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Cancer Institute & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective is to investigate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.
Detailed Description
XELOX is a commonly used chemotherapy regimen, and XELIRI has also been widely used in the second-line treatment. XELOX and XELIRI adopt the three-week regimen, and the single dose of oxaliplatin and irinotecan is large, which has a great impact on the gastrointestinal toxicity and blood toxicity of patients. Therefore, there is no lack of a two-week improved regimen with increased frequency and reduced single dose applied in clinical, so that it has good safety, exact efficacy and increase the drug delivery density. Based on the above, we should not only consider the efficiency of the three drugs, but also control the toxic reaction. The objective is to evaluate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI
Arm Type
Experimental
Arm Description
Induction chemotherapy: Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI: Bevacizumab: 5mg/kg, iv, 30min, d1, 2w; Oxaliplatin: 85mg/㎡, iv, 120min, d1, 4w; Irinotecan: 150mg/㎡, iv, 90min, d15, 4w; Capecitabine: 1000mg/㎡, bid, d2-8, 2w. Maintenance chemotherapy: Bevacizumab: 7.5mg/kg, iv, 30min, d1, q3w; Capecitabine: 1000mg/㎡, bid, d2-15, 2w.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine
Intervention Description
Drug: Bevacizumab 5mg/kg, iv, 30min, d1, 2w; Drug: Oxaliplatin 85mg/㎡, iv, 120min, d1, 4W; Drug: Irinotecan 150mg/㎡, iv, 90min, d15, 4w; Drug: Capecitabine 1000mg/㎡, bid, d2-8, 2w.
Primary Outcome Measure Information:
Title
Progression Free Survival 1 (PFS 1)
Time Frame
28 months
Secondary Outcome Measure Information:
Title
Progression Free Survival 2 (PFS 2)
Time Frame
28 months
Title
Objective Response Rate (ORR)
Time Frame
28 months
Title
Overall Survival (OS)
Time Frame
28 months
Title
The occurrence of adverse reactions (AEs)
Time Frame
28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 years old; Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or with metastasis more than 12 months after radical operation, and the metastasis could not be removed; ECOG score ≤ 2, estimated survival time ≥ 3 months; Leucocytes ≥ 3.5 × 109 / L, neutrophils ≥ 1.5 × 109 / L, hemoglobin ≥ 100g / L, platelets ≥ 80 × 109 / L, serum liver enzyme in patients without liver metastasis is not higher than 2.5 times of the upper limit of normal value, serum liver enzyme in patients with liver metastasis is not higher than 5 times of the upper limit of normal value, serum bilirubin level is not higher than 1.5 times of the upper limit of normal value, serum creatinine level is not higher than 1.5 times of the upper limit of normal value; At least one lesion can be measured by CT or MRI; No other history of malignant tumor; Those who are fertile but willing to take contraceptive measures; Sign the written informed consent. Exclusion Criteria: Patients with allergic, hypersensitive constitution and autoimmune diseases; There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatous lymphangitis, diffuse liver invasion and bone metastasis; No measurable or non assessable lesions; Pregnant or lactated women; Uncontrolled symptomatic brain metastasis or mental disorder can not correctly describe subjective symptoms; Major organ failure; Affecting drug administration, absorption, distribution, metabolism, excretion, etc. the patient has uncontrollable epileptic attack, central nervous system disorder or loss of self-knowledge due to mental disease, physiological or pathological malnutrition, chronic diarrhea, and cachexia; Patients with complete or incomplete ileus; Patients with serious heart disease or history, including documented history of congestive heart failure, high-risk uncontrolled heart rate disorder, angina requiring drug treatment, clinically clear history of heart valve disease, serious myocardial infarction and stubborn hypertension; Severe uncontrollable infection; Alcohol and /or drug abuse or poor compliance of the investigator's judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Liangjun
Phone
+8613770575447
Email
zhulj98@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Sheng
Phone
+8613770768636
Email
lihsh198@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhu Liangjun
Organizational Affiliation
Jiangsu Cancer Institute & Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jiangsu Cancer Institute & Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Liangjun
Phone
+8613905199123
Email
zhulj98@foxmail.com
First Name & Middle Initial & Last Name & Degree
Li Sheng
Phone
+8613770768636
Email
lihsh198@163.com

12. IPD Sharing Statement

Learn more about this trial

A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer

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