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Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). Though nimotuzumab combined with gemcitabine improves survival, there remains scarce clinical data regarding its efficacy in conjunction with AG for treating PCLM. This study aims to evaluate the safety and efficacy of incorporating nimotuzumab with AG for PCLM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG+nimotuzumab | Experimental | Pts with potentially resectable, treatment-naïve PCLM received nimotuzumab (400 mg, iv, d1, qw) and AG chemotherapy (gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nimotuzumab | Drug | nimotuzumab (400 mg, iv, d1, qw) |
| |
| AG chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Primary endpoints were adverse events (AEs), | 3month |
| Measure | Description | Time Frame |
|---|---|---|
| surgical conversion rates | surgical conversion rates | 3month |
| R0 resection rates | R0 resection rates | 3month |
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Inclusion Criteria:
Exclusion Criteria:
1) Prior to this study, the following treatments were received:
Failure to conduct effectiveness and/or safety evaluations; Serious violation of the protocol: While participating in this study, other chemotherapy drugs and/or modern Chinese medicine preparations with anti-cancer indications were used for treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Cancer Hospital Airport Hospital | Recruiting | Tianjin | Tianjin Municipality | 300308 | China |
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| Drug |
(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle) |
|
| pathological complete response (pCR) rate | pathological complete response (pCR) rate | 3month |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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