Resectable Pancreatic Cancer
Conditions
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).
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).
Interventions
DRUGNimotuzumab
Nimotuzumab (400mg) was given weekly
Sponsors
Ruijin Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS） | 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
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival (DFS) | approximately 84 months | DFS is defined as the time from surgical resection to the first tumor recurrence/progression or death due to any cause. |
| locoregional recurrence-free survival (LRRFS) | 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. |
Outcome results
None listed