Clinical trial · Interventional
Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Chemotherapy group
- description
- Treatment with modified-FOLFIRINOX Folic acid 400mg/m\^2, 5- fluorouracil 2400mg/m\^2 for 46h, irinotecan 135mg/m\^2 and oxaliplatin 68mg/m\^2
- type
- EXPERIMENTAL
- label
- Combination group
- description
- Treatment 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
- interventionNames
- Drug: Anti-PD-1 monoclonal antibody
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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