Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-8068 injection in combination with anti-tumor therapies in subjects with colorectal cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Group | Experimental |
| |
| Part B Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068 Injection | Drug | SHR-8068 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | About 7 months. | |
| Progression Free Survival (PFS) | About 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complete Response (cCR) | About 60 months. | |
| Disease Free Survival (DFS) | About 60 months. | |
| Event Free Survival (EFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanpei Huang | Contact | +86-021-61053363 | chuanpei.huang@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adebrelimab Injection |
| Drug |
Adebrelimab injection. |
|
| Bevacizumab Injection | Drug | Bevacizumab injection. |
|
| About 60 months. |
| Overall Survival (OS) | About 60 months. |
| Duration of Response (DoR) | About 18 months. |
| Overall Response Rate (ORR) | About 18 months. |
| Disease Control Rate (DCR) | About 18 months. |
| Adverse Events (AEs) | Up to about 18 months. |
| 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 |