Locally Advanced Pancreatic CancerPhase 2NCT06429904
Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer
A Phase 2 study testing Nimotuzumab+ NALIRIFOX in people with Locally Advanced Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Nimotuzumab+ NALIRIFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to May 2027
- 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
- Age 18-75 years old, gender unlimited;
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- Locally advanced pancreatic cancer, no evidence of distant metastasis as demonstrated by imaging;
- Receive nimotuzumab and NALIRIFOX for voluntary, and patients can tolerate NALIRIFOX by researcher's evaluation;
- No prior tumor systemic therapy.
- Measurable disease according to RECIST criteria v1.1;
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- Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥100×10^9/L; 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;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Postoperative survival was expected to be ≥3 months;
- Fertile subjects are willing to take contraceptive measures during the study period.
- Good compliance and signed informed consent voluntarily.
Who cannot join
- Refuse chemotherapy or surgery;
- History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 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;
- Undergone major surgery within 30 days;
- Use of EGFR-mab or EGFR-TKI within 30 days;
- Known allergy to prescription or any component of the prescription used in this study;
- With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)
- 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.
About this study
Official title: A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).
Read the detailed description
This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC). Patients will receive Nimotuzumab plus NALIRIFOX as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is overall survival (OS). Additional end points included resection rates, progression-free survival (PFS), objective response rate (ORR), safety, etc.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Nimotuzumab+ NALIRIFOX
- Keywords
- Nimotuzumab, locally advanced pancreatic cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab+ NALIRIFOXDrug
Drug: Nimotuzumab Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg, 600mg, 400mg on Day 1, 8, 15, respectively, 28 days as a cycle, up to 6 cycles.
Other Names: h-R3
Drug: NALIRIFOX Patients will receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle, up to 6 cycles.
Other Names: NALIRIFOX
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab combined with NALIRIFOX | Experimental | Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer Receives: Drug: Nimotuzumab+ NALIRIFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
The time from the beginning of treatment to death due to any cause.
Measured: Up to 24 months
Secondary outcomes (5)
resection rate
The proportion of patients who underwent surgery.
Measured: Up to 24 months
progression-free survival (PFS)
PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 24 months
Objective response rate (ORR)
Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.
Measured: Up to 12 months
tumor-related markers
To explore the influence of tumor-related markers such as CA199 and EGFR 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 posted28 May 2024
- Study start15 May 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429904
- Sponsor's protocol ID
- IST-Nim-PC-29
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06429904
- Acronym / sponsor ID
- IST-Nim-PC-29
- Conditions
- Locally Advanced Pancreatic Cancer
- Keywords
- Nimotuzumab, locally advanced pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 May 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, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).
Detailed description
This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC). Patients will receive Nimotuzumab plus NALIRIFOX as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is overall survival (OS). Additional end points included resection rates, progression-free survival (PFS), objective response rate (ORR), safety, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab combined with NALIRIFOX | Experimental | Drug: Nimotuzumab+ NALIRIFOXNimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years old, gender unlimited;
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- Locally advanced pancreatic cancer, no evidence of distant metastasis as demonstrated by imaging;
- Receive nimotuzumab and NALIRIFOX for voluntary, and patients can tolerate NALIRIFOX by researcher's evaluation;
- No prior tumor systemic therapy.
Key exclusion criteria (8 listed)
- Refuse chemotherapy or surgery;
- History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 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;
- Undergone major surgery within 30 days;
- Use of EGFR-mab or EGFR-TKI within 30 days;
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 |
|---|---|---|
| Nimotuzumab+ NALIRIFOXDrug: Nimotuzumab Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg, 600mg, 400mg on Day 1, 8, 15, respectively, 28 days as a cycle, up to 6 cycles. Other Names: h-R3 Drug: NALIRIFOX Patients will receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle, up to 6 cycles. Other Names: NALIRIFOX | Drug | Nimotuzumab combined with NALIRIFOX |
Primary outcome
overall survival (OS)
Time frame: Up to 24 months
The time from the beginning of treatment to death due to any cause.
5 secondary outcomes
resection rate
Time frame: Up to 24 months
progression-free survival (PFS)
Time frame: Up to 24 months
Objective response rate (ORR)
Time frame: Up to 12 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 28 May 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.
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+ NALIRIFOX in people with Locally Advanced Pancreatic Cancer, run by Peking Union Medical College 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 11 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: under way, not looking for participants, as of the sponsor's last update on 28 May 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?
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: 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 28 May 2024.