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| Name | Class |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | INDUSTRY |
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Patients with liver metastasis from esophagus squamous (ESC) are usually offered systemic therapy. However, for those with predominant liver disease or failure of system therapy, local liver management becomes an option. This prospective single center study aimed to evaluate the efficacy and adverse events of hepatic arterial infusion chemotherapy (HAIC) using percutaneous catheter placement techniques for liver metastases from esophagus squamous (ESC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esophageal squamous cell carcinoma with liver metastasis | Experimental | Patients with esophageal squamous cell carcinoma with liver metastasis have poor response to first-line treatment, especially those with advanced esophageal cancer with progression or recurrence in the liver. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAIC combined with intravenous PD-1 | Drug | Hepatic arterial chemoinfusion (HAIC) was used for interventional therapy with at least 2 cycles of hepatic arterial infusion. The intervention was started with sintilimab at the same time, 200mg each time, and the drug was repeated every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Defined as the proportion of patients with Adverse events (AEs), Treatment Emergent Adverse events (TEAEs), Treatment-related AEs (TRAEs), immune-related AEs (irAEs), adverse events of special interest (AESI) and Serious Adverse events (SAE), assessed by NCI CTCAE v5.0 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The response rate of liver metastases | Defined as proportion of patients who have a best response of CR or PR of liver metastases | Up to 2 years |
| The overall response rate ( ORR) | Defined as proportion of patients who have a best response of CR or PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| Up to 2 years |
| The time to response (TTR) | Defined as the time between the date of treatment start and objective tumor response | Up to 2 years |
| The duration of response (DOR) | Defined as the time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first. | Up to 2 years |
| The progression free survival (PFS) | Defined as the time from the date of treatment start to disease progression, or death due to any cause, whichever occurs first. | Up to 2 years |
| The overall survival (OS) | Defined as the time from the date of treatment start to the date of death | Up to 2 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |