Clinical trial · Interventional
Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
NCT04224402CI-TRIAL-00063941completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.
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 Resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFORINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- mFOLFIRINOX
- description
- Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion
- interventionNames
- Drug: mFOLFORINOX
Primary outcomes (1)
- measure
- Regression Free Survival
- timeFrame
- Up to 24 months
- description
- defined as the period from the date of resection to tumor relapse caused by any reason
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients should be voluntary to the trial and provide with signed informed consent. 2. Histologically confirmed diagnosis of pancreatic cancer 3. Male or female, Age: 18-79 years old. 4. No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery. 5. the value of Carbohydrate Antigen19-9(CA19-9) \< 180U/mL within 12 weeks after surgery. 6. No previous chemotherapy 7. Eastern Cooperative Oncology Group(ECOG) performance status of 0-1 8. normal function of organ system including the followings. * No hematologic dysfunction(Platelets ≥90×10\^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L). * Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN. * Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula). 9. ECOG scored as 0-1. 10. Life expectancy \> 3 months. Exclusion Criteria: 1. Patient is concurrently using other antineoplastic agent. 2. Known severe hypersensitivity to drugs in the regimen. 3. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ). 4. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension. 5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction. 6. Evidence of active infection or active epidemic disease. 7. Psychiatric illness that would prevent the patient from giving informed consent 8. Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.