A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer
A Multicenter Phase II Clinical Study of Bevacizumab Combined With Biweekly XELOX/XELIRI Alternative First-line Treatment for Unresectable Advanced Colorectal Cancer
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 30, 2021
August 1, 2021
2.8 years
March 25, 2020
August 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival 1 (PFS 1)
28 months
Secondary Outcomes (4)
Progression Free Survival 2 (PFS 2)
28 months
Objective Response Rate (ORR)
28 months
Overall Survival (OS)
28 months
The occurrence of adverse reactions (AEs)
28 months
Study Arms (1)
Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI
EXPERIMENTALInduction 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009, China
Related Publications (1)
Li S, Li X, Xu H, Huang J, Zhu J, Peng Y, Bao J, Zhu L. Alternating modified CAPOX/CAPIRI plus bevacizumab in untreated unresectable metastatic colorectal cancer: a phase 2 trial. Signal Transduct Target Ther. 2024 Dec 11;9(1):346. doi: 10.1038/s41392-024-02048-z.
PMID: 39658608DERIVED
Study Officials
- STUDY CHAIR
Zhu Liangjun
Jiangsu Cancer Institute & Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ward Director of Internal Medicine
Study Record Dates
First Submitted
March 25, 2020
First Posted
March 27, 2020
Study Start
September 1, 2019
Primary Completion
July 1, 2022
Study Completion
June 1, 2023
Last Updated
August 30, 2021
Record last verified: 2021-08