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

NCT06363084 | Completed

• 1 other identifier: IST-Nim-PC-6
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Resectable Pancreatic Cancer

Outcome Measures

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.

  approximately 84 months

Secondary Outcomes (2)

• disease-free survival (DFS)

  approximately 84 months

• locoregional recurrence-free survival (LRRFS)

  approximately 84 months

Study Arms (2)

study arm

Nimotuzumab plus adjuvant chemotherapy

Drug: Nimotuzumab

control arm

adjuvant chemotherapy alone (without Nimotuzumab)

Interventions

Nimotuzumab DRUG

Nimotuzumab (400mg) was given weekly

Also known as: Taixinsheng

study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Interventions

nimotuzumab

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2016
• Primary Completion: July 31, 2022
• Study Completion: June 30, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share