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NCT Number: NCT03498326

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Qi Chen, MD,PhD

CONTACT

[email protected]

+8613857168284

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old and above.
  • Surgery for R0 resection.
  • The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies.
  • Eastern Cooperative Oncology Group score 0-2 points.
  • Blood routine: The neutrophil count is at least 1.5*10^9/ml, and the platelet count is at least 100*10^9/ml.Hemoglobin is at least 80g/L.
  • Liver function: bilirubin does not exceed 1.5 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase does not exceed the upper limit of normal 3 times; kidney function: creatinine ≤ 1.2 mg/dL.

Exclusion criteria

  • Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma).
  • Surgery for pancreatic cancer fails to reach the R0 resection criteria.
  • Pancreatic cancer received radiotherapy before surgery.
  • Malignant brain metastases.
  • There are other serious cancer history.
  • Active infection, severe diarrhea.
  • Others: Those who are allergic to celecoxib; or who are intolerant to celecoxib, require continuous aspirin or Non-steroidal anti-inflammatory drugs; similar chemical or biological components and sulfa drugs that constitute the study drug History of allergies; allergies, asthma, and rubella after taking aspirin or non-steroidal anti-inflammatory drugs; pregnancy or breastfeeding; active gastrointestinal ulcer/hemorrhage/perforation; Severe mental illness; severe heart failure; past serious cardiovascular thrombotic adverse events, severe hypertensive patients.

Treatment and study plan

Gemcitabine

Drug

One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.

Primary outcomes

  1. disease free survival

    Time frame: Up to approximately 60 months

    the duration between the date of surgery and the date of disease relapse

Secondary outcomes

  1. overall survival

    Time frame: Up to approximately 60 months

    the duration between the date of surgery and the date of patient death

  2. Carbohydrate antigen 19-9

    Time frame: Up to approximately 36 months

    serum Carbohydrate antigen 19-9 level

  3. Quality of Life

    Time frame: Up to approximately 60 months

    assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score

  4. Common Toxicity Criteria for Adverse Effects

    Time frame: Up to approximately 12 months

    according to Common Toxicity Criteria for Adverse Effects version 4

Study contacts

Contact information is provided by the study sponsor or research team.

Tingbo Liang

CONTACT

[email protected]

13666676128

Xueli Bai

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Acronym: GCRP

Important dates

Study start
2018
Primary completion
2023
Study completion
2030
First posted
Apr 13, 2018
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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