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The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cetuximab+chemotherapy | Experimental | XELOX 1 cycle;cetuximab+chemotherapy up to 12 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | 1000mg/m2, bid, d1-d14,q3w,1cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | every 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Around 2 years |
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Inclusion Criteria:
18-75 years (including 18 and 75 years);
ECOG PS 0 or 1;
Colorectal cancer diagnosed histologically and/or cytologically with metastatic or recurrent lesions that are not curable with surgery;
Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;
At least one measurable lesion as defined in RECIST version 1.1;
Fertile patients must be willing to take highly effective pregnancy avoidance measures during the study period and ≥120 days after the last dosing; Female patients with negative urine or serum pregnancy test results within ≤7 days before the first administration of the study drug;
Have fully understood the study and voluntarily signed the informed consent.
Adequate organ and bone marrow function, meeting the following definitions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li hui, bachelor | Contact | 13600855801 | 86 | Lihui7701@163.com |
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| oxaliplatin |
| Drug |
130mg/m2, ivgtt, d1,q3w,1cycle |
|
| Cetuximab | Drug | cetuximab 500mg/m2, q2w |
|
| Oxaliplatin | Drug | 85mg/m2, d1,q2w |
|
| Leucovorin | Drug | 400mg/m2, d1,q2w |
|
| 5-FU | Drug | 400mg/m2,d1,q2w |
|
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D000068818 | Cetuximab |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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