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

NCT03498326 | Recruiting Phase 2

• 1 other identifier: SAHZhejiangU-GCRP
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chemotherapy Effect

Keywords

pancreatic cancer; gemcitabine; celecoxib; R0 resection

Outcome Measures

Primary Outcomes (1)

• disease free survival

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

  Up to approximately 60 months

Secondary Outcomes (4)

• overall survival

  Up to approximately 60 months

• Carbohydrate antigen 19-9

  Up to approximately 36 months

• Quality of Life

  Up to approximately 60 months

• Common Toxicity Criteria for Adverse Effects

  Up to approximately 12 months

Study Arms (2)

gemcitabine

EXPERIMENTAL

one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.

Drug: Gemcitabine

gemcitabine plus celecoxib

EXPERIMENTAL

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

Interventions

Gemcitabine DRUG

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

gemcitabine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Celecoxib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles

Central Study Contacts

Tingbo Liang

CONTACT

13666676128; liangtingbo@zju.edu.cn

Xueli Bai

CONTACT

shirlybai@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of Hepatobiliary & Pancreatic Surgery, Vice president of the Second Affiliated Hospital, Zhejiang University School of Medicine

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 13, 2018
• Study Start: April 2, 2018
• Primary Completion: March 31, 2023
• Study Completion (Estimated): March 31, 2030
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

CN (1)