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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

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.