Clinical trial · Interventional
Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer
A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Gemcitabine is not the first choice for most pancreatic cancer patients nowdays
Summary
Brief summary (as posted)
Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, placebo | Drug | — | UNRESOLVED |
| Mirtazapine plus gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo plus gemcitabine
- description
- we design placebo plus gemcitabine as control arm
- interventionNames
- Drug: Gemcitabine, placebo
- type
- EXPERIMENTAL
- label
- Mirtazapine plus gemcitabine
- description
- We design Mirtazapine plus gemcitabine as experimental arm
- interventionNames
- Drug: Mirtazapine plus gemcitabine
Primary outcomes (1)
- measure
- quality of life
- timeFrame
- up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function. 2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial. 3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled. 4. Patients should be expected to live no shorter than 1.5 months Exclusion Criteria: 1. Patients receiving other anti-cancer drugs; 2. Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation; 3. Patient with inadequate Blood system,liver function and renal function. 4. Brain metastasis is of symptoms 5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease; 6. Chronic enteritis or intestinal obstruction 7. Bone marrow failure 8. Mental disease difficult to control 9. Participated other clinic trial within 3 months 10. Pregnant or lactation patients 11. The researcher evaluate the patient is not suitable for this trial.
References
Publications (0)
Data not yet available