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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy group | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination drug | Drug | Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The period from the first study treatment to any cause of death | Through the study peirod, for 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate | The number of cases received surgery / the total number of evaluable cases (%) | Through the study peirod, for 3 years |
| Objective response rate | The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%) |
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Inclusion Criteria:
•Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
Exclusion Criteria:
•History of participation of other clinical trails within 4 weeks
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37052821 | Derived | Fu Q, Chen Y, Huang D, Guo C, Zhang X, Xiao W, Xue X, Zhang Q, Li X, Gao S, Que R, Shen Y, Wu J, Zhang M, Bai X, Liang T. Sintilimab Plus Modified FOLFIRINOX in Metastatic or Recurrent Pancreatic Cancer: The Randomized Phase II CISPD3 Trial. Ann Surg Oncol. 2023 Aug;30(8):5071-5080. doi: 10.1245/s10434-023-13383-w. Epub 2023 Apr 13. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013812 | Therapeutics |
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| Chemotherapy | Drug | modified-FOLFIRINOX |
|
| Through the study peirod, for 3 years |
| Disease control rate | 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 (%) | Through the study peirod, for 3 years |
| Progression-free survival | The period from the first treatment to the first evaluation of PD or any cause of death | Through the study peirod, for 3 years |
| Adverse effects | Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc. | Through the study peirod, for 3 years |
| Carbohydrate antigen 19-9 | The change of CA 199 | Through the study peirod, for 3 years |
| EORTC QLQ - PAN26 score | The change of the quality of life | Through the study peirod, for 3 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |