Pancreatic Cancer ResectablePhase 2NCT06722911
Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
A Phase 2 study testing Nimotuzumab and AG in people with Pancreatic Cancer Resectable, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- Nimotuzumab and AG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Able and willing to provide a written informed consent.
- 2. Age 18-75 years old, gender unlimited;
- 3. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
- 4. Postoperative pathology suggested R0/R1 resection;
- 5. EGFR positive (by immunohistochemistry);
- 6. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
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- 7. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥80×10^9/L; hemoglobin≥9.0 g/dL; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
- 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- 9. Postoperative survival is expected to be ≥3 months;
- 10. Fertile subjects are willing to take contraceptive measures during the study period.
Who cannot join
- 1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
- 2. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 3. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- 4. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
- 5. CA199\>180 U/ml within 21d before adjuvant therapy;
- 6. Known allergy to prescription or any component of the prescription used in this study;
- 7. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
- 8 .Other reasons that are not suitable to participate in this study according to the researcher\'s judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tao Xia, Dr contact
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Yiping Mou, 0086-057185893643, mouyiping@hmc.edu.cn
About this study
Official title: Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study
This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.
Read the detailed description
This clinical study is designed as a prospective, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (nab-paclitaxel+ gemcitabine) as postoperative adjuvant therapy in patients with EGFR-positive pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.
- Conditions
- Pancreatic Cancer Resectable
- Being tested
- Nimotuzumab, AG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.
AGDrug
Patients will receive nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1,000 mg/m^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab+ AG | Experimental | Not described Receives: Drug: Nimotuzumab; Drug: AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS)
The time from the date of surgery to the disease recurrence or death, whichever is earlier.
Measured: Up to 24 months
Secondary outcomes (4)
distant metastasis-free survival (DMFS)
The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier.
Measured: Up to 24 months
overall survival (OS)
The time from the date of surgery to death due to any cause.
Measured: Up to 24 months
tumor-related markers
To explore the influence of tumor-related markers (such as KRAS gene, CDX-2 protein, etc.) on prognosis.
Measured: Up to 24 months
adverse events
Frequency and severity of adverse events.
Measured: Up to 30 days after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Nov 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiping Mou, Dr, Study chair, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722911
- Sponsor's protocol ID
- IST-Nim-PC-42
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT06722911
- Acronym / sponsor ID
- IST-Nim-PC-42
- Conditions
- Pancreatic Cancer Resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Dec 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 is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.
Detailed description
This clinical study is designed as a prospective, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (nab-paclitaxel+ gemcitabine) as postoperative adjuvant therapy in patients with EGFR-positive pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab+ AG | Experimental | Drug: Nimotuzumab, Drug: AG |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Able and willing to provide a written informed consent.
- 2. Age 18-75 years old, gender unlimited;
- 3. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
- 4. Postoperative pathology suggested R0/R1 resection;
- 5. EGFR positive (by immunohistochemistry);
Key exclusion criteria (8 listed)
- 1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
- 2. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 3. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- 4. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
- 5. CA199\>180 U/ml within 21d before adjuvant therapy;
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 |
|---|---|---|
| NimotuzumabNimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity. | Drug | Nimotuzumab+ AG |
| AGPatients will receive nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1,000 mg/m^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity. | Drug | Nimotuzumab+ AG |
Primary outcome
disease-free survival (DFS)
Time frame: Up to 24 months
The time from the date of surgery to the disease recurrence or death, whichever is earlier.
4 secondary outcomes
distant metastasis-free survival (DMFS)
Time frame: Up to 24 months
overall survival (OS)
Time frame: Up to 24 months
tumor-related markers
Time frame: Up to 24 months
adverse events
Time frame: Up to 30 days after last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 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.
Tao Xia, Dr contact
Yiping Mou, Dr study chair
Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab and AG in people with Pancreatic Cancer Resectable, run by Zhejiang Provincial People's Hospital at 1 site in China.
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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiping Mou, Dr (0086-057185893643, mouyiping@hmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) (time frame: Up to 24 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 9 Dec 2024.