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In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-302 and S-1 Plus Intraperitoneal Paclitaxel | Experimental |
| |
| LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-302, S-1, paclitaxel | Drug | LM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year survival rate | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| treatment related adverse events | up to 24 months | |
| Progressive free survival (PFS) | Progression-free survival (PFS) is defined as the time from enrollemnt to disease progression or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongyin Yang | Contact | 8621-64370045 | jeffreyyong@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Huangpu District | 200025 | China |
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| LM-302, Cadonilimab, S-1, paclitaxel | Drug | LM-302 2.0 mg/kg, Cadonilimab 10mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w. |
|
| up to 36 months |
| Overall survival (OS) | up to 36 months |
| Disease control rate (DCR) | up to 24 months |
| Objective response rate (ORR) | ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1 criteria. | up to 24 months |
| Major Pathological Response (MPR) rate | Defined as tumor specimens resected after conversion surgery with residual tumor cells ≤10% | up to 24 months |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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