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This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX for postoperative adjuvant treatment of pancreatic cancer.
This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX (gemcitabine plus capecitabine) compared with GX only for resected pancreatic cancer. About 146 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus GX) and control group (placebo plus GX) at a ratio of 1:1. The main endpoint is relapse-free survival (RFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (Nimotuzumab+ GX) | Experimental |
| |
| Control group (Placebo+ GX) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| relapse-free survival (RFS) | The time from the date of surgery to the disease recurrence or death, whichever is earlier. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| distant metastasis-free survival (DMFS) | The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier. | Up to 24 months |
| overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuntao Gao, Dr | Contact | 022-2340123 | 3077 | gaochuntao@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Jihui Hao, Dr | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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|
| GX | Drug | Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 days' rest. |
|
| Placebo | Drug | Patients will receive placebo 400 mg weekly or placebo 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months. |
|
The time from the date of surgery to death due to any cause.
| Up to 24 months |
| tumor-related markers | To explore the influence of tumor-related markers (such as KRAS, EGFR) on prognosis. | Up to 24 months |
| adverse events | Frequency and severity of adverse events | Up to 30 days after last administration. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |