A Phase 2 interventional study of Gemcitabine and Gemcitabine in Pancreatic Cancer and Chemotherapy Effect, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2, Interventional, and Treatment
The prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical role in the development and progression of pancreatic cancer. Here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0 resection of pancreatic cancer.
We choose those patients who had underwent the R0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent Celecoxib. The disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on R0 resection pancreatic cancer patients.
Exclusion Criteria:
one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.
Drug: Gemcitabine
the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection, and receive additional celecoxib every days during chemotherapy period.
Drug: Gemcitabine
One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.
the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2, and receive additional celecoxib 200mg bid every days during chemotherapy period.
Also known as: celecoxib
disease free survival
the duration between the date of surgery and the date of disease relapse
Time frame: Up to approximately 60 months
overall survival
the duration between the date of surgery and the date of patient death
Time frame: Up to approximately 60 months
Carbohydrate antigen 19-9
serum Carbohydrate antigen 19-9 level
Time frame: Up to approximately 36 months
Quality of Life
assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score
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 12 months
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Second Affiliated Hospital, School of Medicine, Zhejiang University