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The objective is to investigate the efficacy and safety of envafolimab combined with recombinant human endostatin (endostatin) in the treatment of MSS-type colorectal cancer patients with recurrence or metastasis after failure of second-line standard therapy.
This study is a multicenter, prospective, single-arm clinical study. That is, eligible colorectal cancer patients, after signing the informed consent form, are screened into the group, and will receive continuous intravenous infusion of envafolimab (envafolimab) combined with recombinant human endostatin (endostatin) until the disease. Progressive or intolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Envafolimab plus recombinant human endostatin (endostatin) | Experimental | Envafolimab:300mg,sc,d3,Q3W; endostatin:210mg,civ,d1-3,Q3W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab | Drug | 300mg,sc,d3,Q3W; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | From Baseline to disease progress, up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression Free Survival | From Baseline to primary completion date, about 2 years |
| OS | Overall Survival | From Baseline to primary completion date, about 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enxiao Li | Contact | 0086-13992819833 | doclienxiao@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Enxiao Li | First Affiliated Hospital of Xian Jiaotong University | Study Director |
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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 |
|---|---|
| C000718749 | envafolimab |
| D043169 | Endostatins |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| recombinant human endostatin (endostatin) |
| Drug |
210mg,civ,d1-3,Q3W |
|
| DCR | Disease Control Rate | From Baseline to primary completion date, about 2 years |
| DOR | Duration of Response | From Baseline to primary completion date, about 2 years |
| SAE | severity Adverse Event | From Baseline to primary completion date, about 2 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |