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Completed

NCT Number: NCT06363084

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nimotuzumab

Drug

Nimotuzumab (400mg) was given weekly

Other names: Taixinsheng

Primary outcomes

  1. overall survival (OS)

    Time frame: 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 outcomes

  1. disease-free survival (DFS)

    Time frame: approximately 84 months

    DFS is defined as the time from surgical resection to the first tumor recurrence/progression or death due to any cause.

  2. locoregional recurrence-free survival (LRRFS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Nimotuzumab Plus Adjuvant Chemotherapy vs Adjuvant Chemotherapy Alone for Resectable Pancreatic Cancer: a Propensity Score Matching Analysis

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Apr 12, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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