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

Resectable Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06363084
• Other study ID #: IST-Nim-PC-6
• Status: Completed
• 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
• 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
• 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).

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

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