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Pancreatic Cancer MetastaticPhase 2NCT07920731

A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer

A Phase 2 study testing imotuzumab combined with the NALIRIFOX chemotherapy in people with Pancreatic Cancer Metastatic, run by Fudan University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is a prospective, single-arm study in patients with locally advanced or metastatic pancreatic cancer that cannot be treated with surgery. The study is planned to enroll 42 patients. All patients will receive nimotuzumab combined with the NALIRIFOX chemotherapy regimen as first-line treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer Metastatic
What is being tested?
imotuzumab combined with the NALIRIFOX chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
6 Jun 2026to 10 Aug 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

  • Age 18-75 years, male or female.
  • Histologically and/or cytologically confirmed pancreatic adenocarcinoma.
  • Radiologically confirmed locally advanced or metastatic pancreatic cancer that is not amenable to curative surgery (assessed according to NCCN criteria).
  • ECOG performance status 0-1, and the investigator considers the patient able to tolerate the NALIRIFOX regimen.
  • No prior systemic therapy for pancreatic cancer (including chemotherapy, targeted therapy, or immunotherapy). Prior neoadjuvant or adjuvant therapy is allowed only if recurrence/progression occurred more than 6 months after the last dose and prior treatment-related toxicity has recovered to Grade ≤1 per CTCAE 5.0 (except alopecia or other toxicity judged by the investigator to have no safety risk).
  • At least one measurable lesion per RECIST 1.1. Target lesions must not have received prior radiotherapy or other local therapy; a lesion in a previously irradiated area may be selected as a target lesion if progression has been confirmed and it meets RECIST 1.1 criteria.
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  • Adequate organ and bone marrow function: hemoglobin ≥9.0 g/dL; absolute neutrophil count ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; total bilirubin ≤1.5 × ULN (≤3 × ULN if liver metastasis); AST and ALT ≤2.5 × ULN (≤5 × ULN if liver metastasis); serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
  • Life expectancy of at least 3 months.
  • Women of childbearing potential must agree to use medically accepted contraception during the study.
  • Good compliance and willingness to sign the informed consent form.

Who cannot join

  • Other primary malignancies besides pancreatic cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
  • Other severe diseases, including but not limited to: uncontrolled congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmia, uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg); active infection; poorly controlled diabetes (fasting blood glucose persistently >9.0 mmol/L or HbA1c >7.5% despite glucose-lowering treatment); uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension (e.g., esophageal or gastric varices with a history of bleeding) or portal cavernoma on imaging; gastrointestinal obstruction (including gastric outlet or duodenal obstruction requiring decompression or stenting); respiratory insufficiency (requiring oxygen at rest or arterial oxygen partial pressure <60 mmHg).
  • Major surgery within 4 weeks before first dose of study drug (except puncture biopsy), or unhealed, infected, or dehisced surgical wound.
  • Participation in any clinical trial or receipt of any approved antitumor drug within 4 weeks before screening.
  • History of allergy to the study drugs, similar structural compounds, or their components.
  • Untreated biliary obstruction.
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  • Known HIV or syphilis infection, or current active hepatitis B or C. Active hepatitis B is defined as HBsAg positive with HBV DNA >1000 copies/mL; active hepatitis C is defined as anti-HCV positive with HCV RNA >1000 copies/mL.
  • Pregnant or lactating women.
  • History of severe gastrointestinal disease, such as gastrointestinal bleeding within the past year (e.g., gastric ulcer bleeding or esophageal variceal bleeding), active ulcerative colitis, or Crohn's disease (irinotecan may induce diarrhea, and such underlying diseases may increase toxicity).
  • Other conditions judged by the investigator as unsuitable for this study (e.g., severe malnutrition, psychiatric illness preventing follow-up cooperation, or planned receipt of other antitumor therapy during the study).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • FUSCC

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Prospective, Single-Arm Study of Nimotuzumab Combined With NALIRIFOX Regimen as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer

This is a prospective, single-arm study in patients with locally advanced or metastatic pancreatic cancer that cannot be treated with surgery. The study is planned to enroll 42 patients. All patients will receive nimotuzumab combined with the NALIRIFOX chemotherapy regimen as first-line treatment.

Nimotuzumab is a targeted antibody against EGFR. NALIRIFOX is a standard first-line chemotherapy regimen for advanced pancreatic cancer and includes liposomal irinotecan, oxaliplatin, leucovorin, and 5-FU. Nimotuzumab 400 mg will be given intravenously on Day 1 every 2 weeks. The NALIRIFOX regimen will also be given every 2 weeks. Treatment will continue until the cancer grows or the side effects become unacceptable.

Read more

The main purpose of this study is to find out how long patients live without their cancer getting worse (progression-free survival, PFS). The study will also look at overall survival, tumor response rate, disease control rate, time to progression, and safety, especially serious side effects.

Patients will be followed closely during treatment. Imaging tests will be done every 8 weeks to check the cancer. After treatment ends, patients will be followed for survival for up to 24 months after the last patient is enrolled.

Being tested
imotuzumab combined with the NALIRIFOX chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imotuzumab combined with the NALIRIFOX chemotherapyDrug

    imotuzumab combined with the NALIRIFOX chemotherapy

Study groups in NCT07920731
Study groupRoleWhat they receive
imotuzumab combined with the NALIRIFOX chemotherapyOtherNot described
Receives: Drug: imotuzumab combined with the NALIRIFOX chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS is defined as the time from first antitumor treatment to objective disease progression or death from any cause, whichever occurs first. Tumor response and progression will be assessed by investigators according to RECIST 1.1 using contrast-enhanced CT or MRI every 8 weeks (±7 days) during treatment until disease progression. Patients will be followed for survival after treatment discontinuation.

    Measured: From first antitumor treatment until disease progression or death from any cause, whichever occurs first; assessed throughout treatment and survival follow-up, up to 24 months after the last patient is enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start6 Jun 2026
  3. Primary completion10 Aug 2028 (estimated)
  4. Study completion10 Aug 2028 (estimated)

Resources

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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920731
Sponsor's protocol ID
IST-Nim-PC-89
Status last verified
Nov 2026
First submitted
29 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imotuzumab combined with the NALIRIFOX chemotherapy in people with Pancreatic Cancer Metastatic, run by Fudan University 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 10 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. 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?

Progression-free survival (PFS) (time frame: From first antitumor treatment until disease progression or death from any cause, whichever occurs first; assessed throughout treatment and survival follow-up, up to 24 months after the last patient is enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07920731.

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 6 Nov 2026.

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