A Phase 1/2 interventional study of Sequential Treatment in Pancreatic Adenocarcinoma Metastatic and Chemotherapy Effect, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1/2, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 49 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
One cycle of sequential treatment lasts for 56 days. 1. Stage 1(28 days): AG regimen. Nab-paclitaxel (Abraxane) 125mg/m\^2 + gemcitabine 1000mg/m\^2 (days 1, 8, 15, 28) 2. Stage 2(28 days):mFolfirinox regimen. Fluorouracil 2400 mg/m\^2 continuous intravenous drip 46h + calcium folinate 400 mg/m\^2 + irinotecan 135 mg/m\^2 + oxaliplatin 68 mg/m\^2 (day 1, 15, a total of 28 days). Repeat the cycle above until progression or intolerance of toxicity.
Drug: Sequential Treatment
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.
Also known as: Sequential Treatment With AG and Modified Folfirinox
Progression-free survival
The time of initial response until documented tumor progression.
Time frame: Up to approximately 60 months
Overall survival
The time of initial response until documented patient death.
Time frame: Up to approximately 60 months
Objective response rate
Percentage of people does not get worse for a period of time after diagnosis
Time frame: Up to approximately 60 months
Disease control rate
Percentage of patients whose cancer doesn't progress after treatment
Time frame: Up to approximately 60 months
Carbohydrate antigen 19-9
Serum Carbohydrate antigen 19-9 level
Time frame: 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)
Time frame: Up to approximately 60 months
Common Toxicity Criteria for Adverse Effects
According to Common Toxicity Criteria for Adverse Effects version 4
Time frame: Up to approximately 60 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University