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| Name | Class |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant therapy group | Experimental |
| |
| first-line therapy group | Experimental |
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| ≥second-line therapy group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Arms 1: Neoadjuvant therapy group 20 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Perioperative Sintilimab+IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Arms 1: Neoadjuvant therapy group | Pathological complete regression (pCR): Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist | Approximately 40 months after the first participant is randomized |
| Arms 2: first-line therapy group | Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group. | Approximately 40 months after the first participant is randomized |
| Arms 3:≥second-line therapy group | Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group. | Approximately 40 months after the first participant is randomized |
| Measure | Description | Time Frame |
|---|---|---|
| Arms 1: Neoadjuvant therapy group | R0 resection rate | Approximately 40 months after the first participant is randomized |
| Arms 1: Neoadjuvant therapy group | Event free survival(EFS) |
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Inclusion Criteria:
Applied to Arms 1: Has histologically confirmed gastric/GEJ malignant tumor, and were regarded as having clinical stage T3-T4aN0M0 or T2～4aN+M0
Applied to Arms 2: Had no prior systemic treatment for metastatic disease.
Applied to Arms 3: Received ≥1 prior systemic treatment for metastatic disease.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, professor | Contact | 86-10-88196561 | linshenpku@163.com | |
| Zhi Peng, Associate Professor | Contact | 86-10-88196561 | zhipeng3@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| IBI310 | Drug | Arms 1: Neoadjuvant therapy group, 20 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Perioperative Sintilimab+ IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. |
|
| Approximately 40 months after the first participant is randomized |
| Arms 1: Neoadjuvant therapy group | Objective response rate(ORR) | Approximately 40 months after the first participant is randomized |
| Arms 1: Neoadjuvant therapy group | Disease control rate(DCR) | Approximately 40 months after the first participant is randomized |
| Arms 1: Neoadjuvant therapy group | Overall survival(OS) | Approximately 40 months after the first participant is randomized |
| Arms 1: Neoadjuvant therapy group | Number of participants experiencing clinical and laboratory adverse events (AEs). | Approximately 40 months after the first participant is randomized |
| Arms 2: first-line therapy group | Progression-free survival (PFS） | Approximately 40 months after the first participant is randomized |
| Arms 2: first-line therapy group | Disease control rate (DCR） | Approximately 40 months after the first participant is randomized |
| Arms 2: first-line therapy group | Overall survival (OS） | Approximately 40 months after the first participant is randomized |
| Arms 2: first-line therapy group | ( Number of participants experiencing clinical and laboratory adverse events (AEs). | Approximately 40 months after the first participant is randomized |
| Arms 3:≥second-line therapy group | Progression-free survival (PFS） | Approximately 40 months after the first participant is randomized |
| Arms 3:≥second-line therapy group | Disease control rate (DCR) | Approximately 40 months after the first participant is randomized |
| Arms 3:≥second-line therapy group | Overall survival (OS） | Approximately 40 months after the first participant is randomized |
| Arms 3:≥second-line therapy group | Number of participants experiencing clinical and laboratory adverse events (AEs) | Approximately 40 months after the first participant is randomized |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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