Resectable Pancreatic CancerNCT06363084
A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer
An observational study of Resectable Pancreatic Cancer, run by Ruijin Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Cancer
- What is being tested?
- Nimotuzumab
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Nimotuzumab Plus Adjuvant Chemotherapy vs Adjuvant Chemotherapy Alone for Resectable Pancreatic Cancer: a Propensity Score Matching Analysis
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).
- Conditions
- Resectable Pancreatic Cancer
- Being tested
- Nimotuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called Taixinsheng
Nimotuzumab (400mg) was given weekly
| Study group | Role | What they receive |
|---|---|---|
| study arm | Nimotuzumab plus adjuvant chemotherapy Receives: Drug: Nimotuzumab | |
| control arm | adjuvant chemotherapy alone (without Nimotuzumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 84 months
Secondary outcomes (2)
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.
Measured: approximately 84 months
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.
Measured: approximately 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2016
- Primary completion31 Jul 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363084
- Sponsor's protocol ID
- IST-Nim-PC-6
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimotuzumab Plus Adjuvant Chemotherapy vs Adjuvant Chemotherapy Alone for Resectable Pancreatic Cancer: a Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT06363084
- Acronym / sponsor ID
- IST-Nim-PC-6
- Conditions
- Resectable Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | – | Drug: NimotuzumabNimotuzumab plus adjuvant chemotherapy |
| control arm | – | –adjuvant chemotherapy alone (without Nimotuzumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimotuzumabAlso: TaixinshengNimotuzumab (400mg) was given weekly | Drug | study arm |
Primary outcome
overall survival (OS）
Time frame: 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.
2 secondary outcomes
disease-free survival (DFS)
Time frame: approximately 84 months
locoregional recurrence-free survival (LRRFS)
Time frame: approximately 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Pancreatic Cancer, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS） (time frame: approximately 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.