Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Drug: ChemotherapyDrug: Combination drug
- Registration Number
- NCT03977272
- Lead Sponsor
- Zhejiang University
- Brief Summary
The prognosis of pancreatic cancer is extremely poor. NCCN 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 metastatic pancreatic cancer.
- Detailed Description
Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will assign patients to the treatment after randomization. The primary endpoint is overall survival. Response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
-
•Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
- Recurrent disease or metastatic disease (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.
- Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy
- 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.
- Signed informed consent.
-
•History of participation of other clinical trails within 4 weeks
- History of autoimmune disease or other condition receiving glucocorticoid treatment
- History of receiving chemotherapy within 2 weeks
- History of radiotherapy and molecular target therapy within 2 weeks
- History if active tuberculosis
- History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
- Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
- Hematological precancerous diseases, such as myelodysplastic syndromes.
- 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).
- Immune deficiency syndrome, such as active tuberculosis and HIV infection.
- Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
- Severe serious wounds, ulcers or fractures.
- Clinical evaluation is unacceptable
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy group Chemotherapy 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 Combination group Combination drug 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 200mg.
- Primary Outcome Measures
Name Time Method Overall survival Through the study peirod, for 3 years The period from the first study treatment to any cause of death
- Secondary Outcome Measures
Name Time Method Disease control rate Through the study peirod, for 3 years The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%)
Resection rate Through the study peirod, for 3 years The number of cases received surgery / the total number of evaluable cases (%)
Progression-free survival Through the study peirod, for 3 years The period from the first treatment to the first evaluation of PD or any cause of death
Objective response rate Through the study peirod, for 3 years The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Carbohydrate antigen 19-9 Through the study peirod, for 3 years The change of CA 199
Adverse effects Through the study peirod, for 3 years Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
EORTC QLQ - PAN26 score Through the study peirod, for 3 years The change of the quality of life
Trial Locations
- Locations (1)
the First Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
the First Affiliated Hospital, School of Medicine, Zhejiang University🇨🇳Hangzhou, Zhejiang, China