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Pancreatic CancerPhase 2NCT03983057

Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer

A Phase 2 study testing Anti-PD-1 monoclonal antibody in people with Pancreatic Cancer, run by Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Anti-PD-1 monoclonal antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
1 siteChina
Study dates
1 Apr 2019to 25 Nov 2025
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
  • No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
  • Initial assessment for definitive borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 first edition standard).
  • ECOG score 0 or 1.
  • Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
  • ALT and AST are less than 2 x ULN.
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  • If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
  • Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), platelet count (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).
  • Signed informed consent.

Who cannot join

  • History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
  • History of participation of other clinical trails within 4 weeks
  • History of immunotherapy within 4 weeks
  • History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks
  • Tumor is a local recurrent lesion.
  • Imaging confirmed severe portal hypertension / cavernous transformation.
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  • Ascites
  • Gastric outlet obstruction
  • Respiratory failure requires supplementation of oxygen.
  • Immune deficiency syndrome, such as active tuberculosis and HIV infection.
  • Hematological precancerous diseases, such as myelodysplastic syndromes.
  • Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
  • Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
  • Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
  • Preexisting neuropathy > 1 (NCI CTCAE).
  • Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
  • Severe serious wounds, ulcers or fractures.
  • Confirmed coagulant disease.
  • Clinical evaluation is unacceptable.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with borderline resectable and locally advanced pancreatic cancer.

Read the detailed description

Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, event-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with borderline resectable and locally advanced pancreatic cancer.

Being tested
Anti-PD-1 monoclonal antibody
Keywords
Pancreatic cancer, PD-1, FOLFIRINOX, combination therapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Anti-PD-1 monoclonal antibodyDrug

    Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.

Study groups in NCT03983057
Study groupRoleWhat they receive
Chemotherapy groupNo interventionTreatment with modified-FOLFIRINOX Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
Combination groupExperimentalTreatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2, Anti-PD-1 antibody 3mg/kg
Receives: Drug: Anti-PD-1 monoclonal antibody

What is being measured

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

  1. Event-free survival

    Event-Free Survival assessed by the investigator according to RECIST 1.1 by investigator, defined as the interval from randomization to the first occurrence of disease progression, local or distant recurrence, or death from any cause.

    Measured: From randomization to any of the following events: disease progression, local or distant recurrence, or death from any cause, whichever occurs first. Up to approximately 60 months.

Secondary outcomes (7)

  1. Overall survival

    From randomization to death due to any cause.

    Measured: From randomization to death due to any cause. Up to approximately 60 months.

  2. Objective response rate

    The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

    Measured: Up to approximately 60 months.

  3. Disease control rate

    The proportion of patients with tumor size reduction or stable

    Measured: Up to approximately 60 months.

  4. Resection rate

    The proportion of patients with surgical treatment after treatment

    Measured: Up to approximately 60 months.

  5. R0 rate

    The proportion of patients with completely tumor resection after treatment

    Measured: Up to approximately 60 months.

  6. Adverse effects

    The most common hematologic and non-hemotologic adverse events

    Measured: Up to approximately 60 months.

  7. Carbohydrate antigen 19-9

    Carbohydrate antigen 19-9 level

    Measured: Up to approximately 60 months.

Timeline

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

  1. First posted12 Jun 2019
  2. Study start1 Apr 2019
  3. Primary completion25 Nov 2025
  4. Study completion25 Nov 2025

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03983057
Sponsor's protocol ID
CISPD-4
Status last verified
Feb 2026
First submitted
5 Jun 2019
Last updated
11 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-PD-1 monoclonal antibody in people with Pancreatic Cancer, run by Zhejiang 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 9 inclusion and 19 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 11 Feb 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?

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?

Event-free survival (time frame: From randomization to any of the following events: disease progression, local or distant recurrence, or death from any cause, whichever occurs first. Up to approximately 60 months.). 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 NCT03983057.

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 11 Feb 2026.

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