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The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of RC48 combined withSintilimab and chemotherapy in perioperative therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Neoadjuvant therapy:RC48 combined with Sintilimab and XELOX repeat every 2 weeks or every 3 weeks for a total of 3 cycles Adjuvant therapy: RC48 combined with Sintilimab and XELOX repeat every 2 weeks or every 3 weeks for a total of 5 cycles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC48 combined with Sintilimab and XELOX | Drug | RC48: 2.5 mg/kg, iv, d1, repeat every 2 weeks; Sintilimab: 200mg, iv, d1, repeat every 3 weeks; XELOX: Oxaliplatin 130mg/m2, iv, d1ï¼›Capecitabine1000 mg po, bid, d1-14, repeat every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) rate | The percentage of patients with no residual cells at the primary cancer site and N(-) per histological evaluation. | Up to approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The percentage of patients who have no residual cancer cells (gross or microscopically) at the resection margins. | Up to approximately 12 weeks |
| Disease free survival (DFS) | DFS is defined as the time from postoperative baseline imaging evaluation to disease recurrence or death in subjects who are disease-free after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Liu | Contact | +86-13783604602 | yaya7207@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Liu | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C519688 | XELOX |
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RC48+PD-1+chemotherapy
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|
| From randomization to the date of recurrence or death (up to approximately 4 years). |
| Major pathological response (MPR) rate | Up to approximately 12 weeks |
| Clinical downgrading rate | Up to approximately 12 weeks |
| Overall survival (OS) | OS is defined as the time from the first dose to all-cause death. | From the randomization to the date of death (up to approximately 4 years). |
| Percentage of Participants who experience one or more adverse events (AEs). | The incidence and grade of adverse events (including SAE) will be determined per NCI-CTCAE 5.0. | Up to approximately 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |