New combo therapy aims to tackle tough pancreatic cancer
NCT ID NCT03983057
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed phase 2 trial tested whether adding an anti-PD-1 immunotherapy drug to standard chemotherapy (modified-FOLFIRINOX) helps patients with locally advanced or borderline resectable pancreatic cancer. The study enrolled 392 participants and compared the combination against chemotherapy alone. The goal was to see if the combo improves event-free survival, overall survival, and tumor shrinkage rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-PD-1 antibody (immunotherapy) combined with modified-FOLFIRINOX chemotherapy
- What this could lead to
- If successful, this combination could improve tumor shrinkage and delay progression in patients with pancreatic cancer that hasn't spread, potentially making more tumors operable.
- What could go wrong
- This is a phase 2 trial, so results are still early. The added immunotherapy may increase side effects without guaranteeing better survival, and not all patients may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
392 people
The number who actually took part.
- Started
-
Apr 2019
- Finished
-
Nov 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pancreatic cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood test before pancreatic surgery predict a dangerous leak?
- New chemo cocktail targets pancreatic cancer at every stage
- Bacteria-Based immunotherapy targets pancreatic tumors in first human test
- Can a new radiation machine cut breath holds for cancer patients?
- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors
- Can a phone app help pancreatic cancer patients eat better during treatment?