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After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi
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The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI310 + Sintilimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI310 (anti-CTLA-4 antibody) | Biological | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR in all MSI-H CRC patients based on investigator assessment. | Up to 3 years | |
| Progression-Free Survival (PFS) both by investigator and IRC | Up to 3 years | |
| Disease Control Rate (DCR) both by investigator and IRC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Beijing | China |
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| Sintilimab(anti-PD-1 antibody) |
| Biological |
Specified dose on specified days |
|
| Up to 3 years |
| Duration of Response (DoR) both by investigator and IRC | Up to 3 years |
| Time To Response (TTR) both by investigator and IRC | Up to 3 years |
| Overall Survival | Up to 3 years |
| Incidence of adverse events (AE) | Up to 3 years |
| 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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