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CompletedNCT06363084Updated Apr 12, 2024

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

An observational study in Resectable Pancreatic Cancer, sponsored by Ruijin Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
64
Ages
18 Years and older
Sex
All
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Study 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).

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

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Conditions studied

  • Resectable Pancreatic Cancer
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 64 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer

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

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • study arm

    Nimotuzumab plus adjuvant chemotherapy

    Drug: Nimotuzumab

  • control arm

    adjuvant chemotherapy alone (without Nimotuzumab)

Interventions

  • DrugNimotuzumab

    Nimotuzumab (400mg) was given weekly

    Also known as: Taixinsheng

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What researchers measure

Primary outcomes

  1. overall survival (OS)

    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.

    Time frame: approximately 84 months

Secondary outcomes

  1. disease-free survival (DFS)

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

    Time frame: approximately 84 months

  2. locoregional recurrence-free survival (LRRFS)

    LRRFS is defined as the time from surgical treatment to clinically or radiographically confirmed local recurrence and/or regional progression at follow-up.

    Time frame: approximately 84 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06363084
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
May 1, 2016
Primary completion
Jul 31, 2022
Completion
Jun 30, 2023
Last update
Apr 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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