NCT03498326 Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
| NCT ID | NCT03498326 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2018-04-02 |
| Primary Completion | 2023-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 480 participants in total. It began in 2018-04-02 with a primary completion date of 2023-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03498326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03498326 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03498326 currently recruiting?
Yes, NCT03498326 is actively recruiting participants. Contact the research team at liangtingbo@zju.edu.cn for enrollment information.
Where is the NCT03498326 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT03498326 clinical trial?
NCT03498326 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 480 participants.
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