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This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSGJ-707(dose 1)+ XELOX | Experimental |
| |
| SSGJ-707(dose 1)+ mFOLFOX6 | Experimental |
| |
| SSGJ-707(dose 2)+ XELOX | Experimental |
| |
| SSGJ-707(dose 2)+ mFOLFOX6 | Experimental |
| |
| SSGJ-707+XELOX/mFOLFOX6 | Experimental |
| |
| Bevacizumab+XELOX/mFOLFOX6 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSGJ-707 | Drug | bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 12 months |
| Safety and tolerability | Safety and tolerability assessed by incidence and severity of adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The efficacy end points | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liu Tianshu | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| SSGJ-707 monotherapy | Experimental |
|
| Bevacizumab | Drug | VEGF antibody |
|
| Oxaliplatin | Drug | chemotherapy |
|
| Capecitabine | Drug | chemotherapy |
|
| Calcium Folinate | Drug | chemotherapy |
|
| 5-fluorouracil | Drug | chemotherapy |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| 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 |