Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Chemotherapy group 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 |
Drug: Chemotherapy
modified-FOLFIRINOX
|
| Experimental: Combination group 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. |
Drug: Combination drug
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
|
Outcome Measures
Primary Outcome Measures
- Overall survival [Through the study peirod, for 3 years]
The period from the first study treatment to any cause of death
Secondary Outcome Measures
- Resection rate [Through the study peirod, for 3 years]
The number of cases received surgery / the total number of evaluable cases (%)
- 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 (%)
- 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 (%)
- 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
- 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.
- Carbohydrate antigen 19-9 [Through the study peirod, for 3 years]
The change of CA 199
- EORTC QLQ - PAN26 score [Through the study peirod, for 3 years]
The change of the quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
-
•Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
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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.
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Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy
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ECOG score 0 or 1.
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Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
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ALT and AST are less than 2 x ULN.
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Signed informed consent.
Exclusion Criteria:
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•History of participation of other clinical trails within 4 weeks
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History of autoimmune disease or other condition receiving glucocorticoid treatment
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History of receiving chemotherapy within 2 weeks
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History of radiotherapy and molecular target therapy within 2 weeks
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History if active tuberculosis
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History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
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Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
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Hematological precancerous diseases, such as myelodysplastic syndromes.
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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
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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)
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Preexisting neuropathy > 1 (NCI CTCAE).
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Immune deficiency syndrome, such as active tuberculosis and HIV infection.
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Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
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Severe serious wounds, ulcers or fractures.
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Clinical evaluation is unacceptable
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CISPD3