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This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab |
|
| Treatment group B | Active Comparator | Standard First-line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab | Drug | SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC) | From the first dose to the last visit, approximately11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) | From the first dose to the last visit, approximately 11months | |
| Duration of Response (DoR) assessed by Independent Review Committee (IRC) | From the first dose to the last visit, approximately 11months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingyi Jiang | Contact | 0518-82342973 | yingyi.jiang.yj58@hengrui.com | |
| Zhengjin Zhang | Contact | 0518-82342973 | zhengjin.zhang.zz79@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab | Drug | Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab |
|
| Progression-Free Survival (PFS) assessed by the Investigator | From the first dose to the last visit, approximately11 months |
| Objective Response Rate (ORR) assessed by the Investigator | From the first dose to the last visit, approximately 11 months |
| Duration of Response (DoR) assessed by the Investigator | From the first dose to the last visit, approximately 11 months |
| Overall Survival (OS) | From the first dose to the last visit, approximately 11 months |
| Incidence and severity of Adverse Events (AEs). | From the first dose to the last visit, approximately11 months |
| Anti-SHR-A1811 Antibodies (ADA) | From the first dose to the last visit, approximately 11 months |
| Plasma concentrations of toxin-conjugated antibody of SHR-A1811 | From the first dose to the last visit, approximately 11 months |
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D058766 | Levoleucovorin |
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002955 | Leucovorin |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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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