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

Phase 2

Recruiting

• Conditions: Chemotherapy Effect; Pancreatic Cancer
• Interventions: Drug: Gemcitabine

• Registration Number: NCT03498326
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-04-02
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-07
• Study First Posted: 2018-04-13
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-27
• Last Update Posted: 2018-05-30
• Primary Completion: 2023-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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 of other malignancies.
4. Eastern Cooperative Oncology Group score 0-2 points.
5. 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.
6. 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.

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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 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gemcitabine	Gemcitabine	one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.
gemcitabine plus celecoxib	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.

Primary Outcome Measures

Name	Time	Method
disease free survival	Up to approximately 60 months	the duration between the date of surgery and the date of disease relapse

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Up to approximately 60 months	assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score
overall survival	Up to approximately 60 months	the duration between the date of surgery and the date of patient death
Carbohydrate antigen 19-9	Up to approximately 36 months	serum Carbohydrate antigen 19-9 level
Common Toxicity Criteria for Adverse Effects	Up to approximately 12 months	according to Common Toxicity Criteria for Adverse Effects version 4

Trial Locations

Locations (1)

the second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China