Combining Gemcitabine and Celecoxib for Pancreatic Cancer Treatment
Official title: Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT03498326 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | April 2, 2018 |
| Main results expected | March 31, 2023 |
| Study ends | March 31, 2030 |
| Registry record updated | May 30, 2018 |
| Trial ID | NCT03498326 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have undergone successful R0 resection for pancreatic ductal adenocarcinoma.
✕Probably not a fit
Patients with other types of pancreatic cancer or those who have not achieved R0 resection will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While gemcitabine is a standard treatment, the combination with celecoxib is a novel approach that has not been extensively tested in this context.
Who can join: the full rules
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 it's running
-
the second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Tingbo Liang
- Email: liangtingbo@zju.edu.cn
- Phone: 13666676128
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.