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The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox on metastatic pancreatic adenocarcinoma.
Investigators chose metastatic pancreatic adenocarcinoma patients who can't meet surgical criteria. The planned treatment was given to the participants after enrollment. Objective remission rate, disease control rate, tumor size, progression-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't effectively control the progress of metastatic pancreatic adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential treatment | Experimental | One cycle of sequential treatment lasts for 56 days.
Repeat the cycle above until progression or intolerance of toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential Treatment | Drug | One cycle of the treatment lasts for 56 days. Patients will receive chemotherapy based on Nab-paclitaxel Plus Gemcitabine and modified Folfirinox in sequence order. The cycle will repeat until progression or intolerance of toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The time of initial response until documented tumor progression. | Up to approximately 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time of initial response until documented patient death. | Up to approximately 60 months |
| Objective response rate | Percentage of people does not get worse for a period of time after diagnosis |
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Inclusion Criteria:
Histologically or cytologically diagnosed metastatic pancreatic adenocarcinoma (excluding islet cell tumor) that can be measured according to RECIST criteria.
Without Radiotherapy, surgery, chemotherapy or experimental treatment for metastatic pancreatic cancer. Previous use of 5-FU or gemcitabine as a radiosensitizer in adjuvant therapy is allowed, but it should be taken at least 6 months ago and no residual toxicity. Patients receiving cytotoxic doses of gemcitabine or any other chemotherapy in adjuvant therapy are not eligible for this study.
ECOG score 0-1 points.
The first diagnosis time of metastatic pancreatic cancer should be within 6 weeks of the initial of treatment. Note: This interval is calculated from the date of final assessment of the confirmed pancreatic cancer metastasis.
No jaundice symptoms before treatment. Pain should be stable, and no need to adjust analgesic treatment. Patients with obvious or symptomatic ascites should be drained before treatment.
With enough blood cell counts during the screening period(less than 14 days before the treatment): 1) The absolute count of neutrophils(ANC) is more than 1.5 ×10^9/L; 2) Platelet count was greater than 100,000/mm^3 (100 x10^9/L); 3).
Hemoglobin (Hgb) is more than 9 g/dL.
With normal blood biochemical parameters during the screening period(less than 14 days before the treatment): 1). AST (SGOT), ALT (SGPT) <2.5*ULN, if there is obvious liver metastasis, it is allowed to <5*ULN. 2). Total bilirubin is less than ULN. 3). Serum creatinine is within the normal limit, or the serum creatinine level is higher or lower than the normal value of the body, but the calculated clearance rate is more than 60 mL/min/1.73 m^2. If creatinine clearance is used, the actual body weight should be used to calculate creatinine clearance (for example, the Cockroft-Gault formula). Patients with body mass index (BMI) >30 kg/m^2 should use fat free body weight.
Acceptable coagulation test results (less than 14 days before treatment): prothrombin time (PT) and partial thromboplastin time (PPT) were within the normal limit (+15%).
With no clinically significant abnormal urine analysis (less than 14 days before treatment).
Male or non pregnant and non lactating women aged 18 or above who signed the informed consent.
Patients were informed of the nature of the study and agreed to participate in the study, and informed consent was signed before participating in any research-related activities.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingbo Liang, MD PhD | Contact | 8613666676128 | liangtingbo@zju.edu.cn | |
| Qi Zhang, MD | Contact | 8613819137113 | zhangqi86@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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|
| Up to approximately 60 months |
| Disease control rate | Percentage of patients whose cancer doesn't progress after treatment | Up to approximately 60 months |
| Carbohydrate antigen 19-9 | Serum Carbohydrate antigen 19-9 level | Up to approximately 60 months |
| EORTC QLQ - PAN26 | Assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score(EORTC QLQ - PAN26) | Up to approximately 60 months |
| Common Toxicity Criteria for Adverse Effects | According to Common Toxicity Criteria for Adverse Effects version 4 | Up to approximately 60 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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