A Phase 2 interventional study of Nimotuzumab and AG regimen in Pancreatic Cancer, Adult, sponsored by Biotech Pharmaceutical Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Biotech Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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 nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable/borderline resectable 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 nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer. About 156 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus AG) and control group (placebo plus AG) at a ratio of 1:1. The main endpoint is disease-free survival (DFS). Additional end points include overall survival (OS), R0 resection rate, preoperative objective response rate (ORR), postoperative complications and safety, etc.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 156 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Biotech Pharmaceutical Co., Ltd. is the lead sponsor of 31 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Drug: Nimotuzumab · Drug: AG regimen
Drug: AG regimen · Drug: Placebo
Patients will receive 3 cycles of neoadjuvant treatment with Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).
Patients will receive 3 cycles of AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle).
Patients will receive 3 cycles of neoadjuvant treatment with placebo (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant therapy (placebo 400 mg on days 1, 8, and 15 of a 21-day cycle).
disease-free survival (DFS)
The time from the date of surgery to the disease recurrence or death, whichever is earlier.
Time frame: Up to 24 months
overall survival (OS)
The time from the date of randomization to death due to any cause.
Time frame: Up to 24 months
R0 resection rate
Pathologic review will determine if an R0 resection has been performed. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Time frame: within 30 days after surgery
Surgical Resection rate
Patients who undergo surgical resection will be documented.
Time frame: within 30 days after surgery
Objective response rate (ORR)
Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.
Time frame: Up to 9 weeks during the neoadjuvant treatment]
adverse events
Frequency and severity of adverse events.
Time frame: Up to 30 days after last administration
Plan to share: No
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Biotech Pharmaceutical Co., Ltd.