Combining Gemcitabine and Celecoxib for Pancreatic Cancer Treatment
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
This study is testing if adding celecoxib to gemcitabine can help people who have had surgery for pancreatic cancer live longer and stay cancer-free.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT03498326 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining gemcitabine with celecoxib in patients who have undergone R0 resection for pancreatic ductal adenocarcinoma. Participants are randomly assigned to receive either gemcitabine alone or the combination therapy. The study aims to evaluate disease-free survival, overall survival, and side effects associated with the treatments. By assessing the potential synergistic effects of celecoxib, the trial seeks to improve outcomes for patients with this challenging cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone successful R0 resection for pancreatic ductal adenocarcinoma.
Not a fit: Patients with other types of pancreatic cancer or those who have not achieved R0 resection will not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could significantly enhance survival rates for patients with resected pancreatic cancer.
How similar studies have performed: While gemcitabine is a standard treatment, the combination with celecoxib is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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.
Where this trial is running
Hangzhou, Zhejiang
- the second affiliated hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Tingbo Liang
- Email: liangtingbo@zju.edu.cn
- Phone: 13666676128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.