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This is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of Initial unresectable gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transarterial Chemoembolization | Drug | Arterial infusion chemotherapy (THP + oxaliplatin + raltitrexed) and THP combined with lipiodol embolization for 2 times, with an interval of 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation | Objective response rate (ORR): complete response (CR) + partial response (PR). Evaluation methods: Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria. Complete Remission (CR): All target and non-target lesions disappeared, no new lesions; Partial Remission (PR): Compared with baseline, tumor burden decreased by ≥30%, and non-target lesions did not progress significantly , no new lesions; Stable Disease (SD): neither PR nor PD; Progressive Disease (PD): tumor burden increased by ≥20%, and the absolute value increased by at least 5mm, or non-target lesions progressed, or new lesions (reconfirm progression after at least 6 weeks). | up to 3 years |
| Surgical resection rate | Surgical resection rate: The rate of surgical resection is transformed from those who cannot undergo radical surgical resection and one-stage anastomosis after treatment. | up to 3 years |
| PFS | Progression-free survival(PFS) is defined as the time between the date of randomization and any documented tumor progression or death from any cause. | up to 3 years |
| OS | Overall survival (OS), defined as the time from study entry (ie, signing the ICF) to death from any cause. For subjects who were alive at the last contact, their overall survival was censored on the date of the last contact. | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Wu, MD | Contact | +86 13938570175 | wuganghenan2015@163.com |
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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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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |