A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Completed

• Conditions: Resectable Pancreatic Cancer
• Interventions: Drug: Nimotuzumab

• Registration Number: NCT06363084
• Lead Sponsor: Ruijin Hospital

Brief Summary

This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).

Detailed Description

This trial is a retrospective, observational study based on real-world data obtained from the Health Information System (HIS) of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups accor...

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-05-01
• Primary Completion: 2022-07-31
• Study Completion: 2023-06-30
• Status Verified: 2024-03
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age≥18 years old, gender is not limited;
• Confirmed by histopathological or cytological diagnosis of pancreatic cancer;
• Underwent surgical resection of the pancreas for non-metastatic pancreatic cancer (including resectable/borderline resectable pancreatic cancer, or locally advanced pancreatic cancer);
• Received Nimotuzumab plus adjuvant chemotherapy or adjuvant chemotherapy alone after surgery.

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Exclusion Criteria

• Patients with other primary malignancies other than pancreatic cancer;
• Evidence of recurrence or distant metastasis before surgery
• Received immunotherapy drugs (such as PD-1 inhibitors, etc.) used during adjuvant therapy, or proprietary Chinese medicines with anti-tumor indications, or hyperthermia, targeted therapy drugs other than nimotuzumab;
• Key information is missing (e.g., primary endpoint data were not available).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study arm	Nimotuzumab	Nimotuzumab plus adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
overall survival (OS）	approximately 84 months	The primary endpoint is overall survival (OS), defined as the time from the start of surgery to the date of death due to any cause.

Secondary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	approximately 84 months	DFS is defined as the time from surgical resection to the first tumor recurrence/progression or death due to any cause.
locoregional recurrence-free survival (LRRFS)	approximately 84 months	LRRFS is defined as the time from surgical treatment to clinically or radiographically confirmed local recurrence and/or regional progression at follow-up.