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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival 1 (PFS 1) | 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival 2 (PFS 2) | 28 months | |
| Objective Response Rate (ORR) | 28 months | |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Liangjun | Contact | +8613770575447 | zhulj98@foxmail.com | |
| Li Sheng | Contact | +8613770768636 | lihsh198@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhu Liangjun | Jiangsu Cancer Institute & Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Institute & Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39658608 | Derived | 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. |
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| 28 months |
| The occurrence of adverse reactions (AEs) | 28 months |