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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06363084
Other study ID # IST-Nim-PC-6
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2016
Est. completion date June 30, 2023

Study information

Verified date March 2024
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date June 30, 2023
Est. primary completion date July 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nimotuzumab
Nimotuzumab (400mg) was given weekly

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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. approximately 84 months
Secondary 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. approximately 84 months
Secondary 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. approximately 84 months
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