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

NCT ID: NCT06363084

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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 according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).

Conditions

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Resectable Pancreatic Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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study arm

Nimotuzumab plus adjuvant chemotherapy

Nimotuzumab

Intervention Type DRUG

Nimotuzumab (400mg) was given weekly

control arm

adjuvant chemotherapy alone (without Nimotuzumab)

No interventions assigned to this group

Interventions

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Nimotuzumab

Nimotuzumab (400mg) was given weekly

Intervention Type DRUG

Other Intervention Names

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Taixinsheng

Eligibility Criteria

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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.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IST-Nim-PC-6

Identifier Type: -

Identifier Source: org_study_id

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