Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Drug: Anti-PD-1 monoclonal antibody
- Registration Number
- NCT03983057
- Lead Sponsor
- Zhejiang University
- Brief 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.
- Detailed Description
Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, recurrence-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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 830
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination group Anti-PD-1 monoclonal antibody 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
- Primary Outcome Measures
Name Time Method Progression-free survival Through the study peirod, for 3 years The time of treatment until documented tumor progreesion.
- Secondary Outcome Measures
Name Time Method Resection rate Through the study peirod, for 3 years The proportion of patients with surgeical treatment after treatment
R0 rate Through the study peirod, for 3 years The proportion of patients with completely tumor resection after treatment
Objective response rate Through the study peirod, for 3 years The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Disease control rate Through the study peirod, for 3 years The proportion of patients with tumor size reduction or stable
Overall survival Through the study peirod, for 3 years The time of treatment until death.
Adverse effects Through the study peirod, for 3 years The most common hematologic and non-hemotologic adverse events
EORTC QLQ - PAN26 score Through the study peirod, for 3 years QLQ score assessed by the European Organization for Research and Treatment of Cancer Quality of Life scale for pancreatic cancer
Carbohydrate antigen 19-9 Through the study peirod, for 3 years Carbohydrate antigen 19-9 level
Trial Locations
- Locations (1)
the First Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China