Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer

Last updated: May 27, 2018
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Disorders

Pancreatic Cancer

Pancreatitis

Treatment

N/A

Clinical Study ID

NCT03498326
SAHZhejiangU-GCRP
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years old and above.

  2. Surgery for R0 resection.

  3. The gemcitabine chemotherapy regimen was not previously used for the treatment ofother malignancies.

  4. Eastern Cooperative Oncology Group score 0-2 points.

  5. Blood routine: The neutrophil count is at least 1.510^9/ml, and the platelet count isat least 10010^9/ml.Hemoglobin is at least 80g/L.

  6. Liver function: bilirubin does not exceed 1.5 times the upper limit of normal; alanineaminotransferase and aspartate aminotransferase does not exceed the upper limit ofnormal 3 times; kidney function: creatinine ≤ 1.2 mg/dL.

Exclusion

Exclusion Criteria:

  1. Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma).

  2. Surgery for pancreatic cancer fails to reach the R0 resection criteria.

  3. Pancreatic cancer received radiotherapy before surgery.

  4. Malignant brain metastases.

  5. There are other serious cancer history.

  6. Active infection, severe diarrhea.

  7. Others: Those who are allergic to celecoxib; or who are intolerant to celecoxib,require continuous aspirin or Non-steroidal anti-inflammatory drugs; similar chemicalor biological components and sulfa drugs that constitute the study drug History ofallergies; allergies, asthma, and rubella after taking aspirin or non-steroidalanti-inflammatory drugs; pregnancy or breastfeeding; active gastrointestinalulcer/hemorrhage/perforation; Severe mental illness; severe heart failure; pastserious cardiovascular thrombotic adverse events, severe hypertensive patients.

Study Design

Total Participants: 480
Study Start date:
April 02, 2018
Estimated Completion Date:
March 31, 2030

Study Description

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.

Connect with a study center

  • the second affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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