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| ID | Type | Description | Link |
|---|---|---|---|
| U25A20115 | Other Grant/Funding Number | National Natural Science Foundation of China |
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Patients with T4N+ or T1-3N2 disease will be randomly assigned to either the control group (FOLFOX/CAPOX for 6 months) or the intervention group (FOLFOX/CAPOX plus bevacizumab for 6 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months postoperatively for dynamic monitoring of plasma ctDNA.
Patients with T4N+ or T1-3N2 disease will be randomly assigned to either the control group (FOLFOX/CAPOX for 6 months) or the intervention group (FOLFOX/CAPOX plus bevacizumab for 6 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months postoperatively for dynamic monitoring of plasma ctDNA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doublet chemotherapy group | Active Comparator | Patients with T4N+ or T1-3N2 disease assigned to control group will receive FOLFOX/CAPOX for 6 months |
|
| doublet chemotherapy + BEV group | Experimental | Patients with T4N+ or T1-3N2 disease assigned to intervention group will receive FOLFOX/CAPOX plus bevacizumab for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX | Drug | FOLFOX for 6 months |
| |
| Folfox plus Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's 2-year Progression-Free Survival | Two-year Progression-Free Survival (PFS) is defined as the proportion of patients who remain alive without evidence of disease progression or recurrence within 24 months from the date of surgery (or randomization, as specified in the protocol). Disease progression is determined according to radiologic, clinical, or pathological criteria. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA-clearance Rate | ctDNA clearance rate is defined as the proportion of patients with detectable circulating tumor DNA (ctDNA) at baseline who achieve conversion to undetectable ctDNA at a predefined post-treatment time point, as assessed by the specified ctDNA assay. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoxiang Cai | Contact | 86-18017312703 | gxcaifuscc@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| Drug |
FOLFOX plus Bevacizumab for 6 months |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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